Location: Woodlawn, MD
Company: HHS Careers
and plan-related analyses to understand the services provided by CMS. Duties Developing and conducting survey, market research, and statistical methodologies and techniques to identify and understand CMS programs and the needs and preferences of the beneficiaries we serve.
Analyzing the quality and performance of health plans. Planning, directing, and monitoring activities involved in conducting surveys of beneficiary populations, including for the Consumer backssment of Healthcare Providers and Systems Surveys. Interpreting data tabulations and graphs, and identifying critical factors such as data limitations, biases, sampling errors, and inconsistencies. Serving as liaison with representatives
of the health care and human services industry to obtain input, and promote understanding of beneficiary and plan-related issues. Preparing various forms of written documents to address technical and non-technical audiences.
Requirements Conditions of Employment You must be a U. S. Citizen or National to apply for this position. You will be subject to a background and suitability investigation. Qualifications ALL QUALIFICATION REQUIREMENTS MUST BE MET BY THE CLOSING DATE OF THIS ANNOUNCEMENT. Your resume must include detailed information as it relates to the responsibilities and specialized experience for this position. Evidence of copying and pasting directly from the vacancy announcement
without clearly documenting supplemental information to describe your experience will result in an ineligible rating.
This will prevent you from receiving further consideration. In order to qualify for the GS-13 , you must meet the following: You must demonstrate in your resume at least one year (52 weeks) of qualifying specialized experience equivalent to the GS-12 grade level in the Federal government, obtained in either the private or public sector, to include: 1. Lead research studies such as studies that include the development and implementation of surveys of patients or individuals; 2. Recommend modifications of operational policy or procedures based on the data analysis received from research studies; AND 3.
Interpret or conduct complex statistical analyses with large datasets. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e. g. Peace Corps, Ameri Corps) and other organizations (e. g. professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
How You Will Be Evaluated You will be evaluated for this job based on how well you meet the qualifications above. You will be evaluated based on how well you meet the qualifications listed in this vacancy announcement. Your qualifications will be evaluated based on your application materials (e. g. resume, supporting documents), the responses you provide on the application questionnaire, and the result of the online backssments required for this position. Please follow all instructions carefully. Errors or omissions may affect your rating.
You will be backssed on the following competencies (knowledge, skills, abilities, and other characteristics): Analysis Attention to Detail Building Coalitions/Communications Flexibility Integrity/Honesty Interpersonal Skills Learning Reading Comprehension Research Self-Management Stress Tolerance Teamwork Technical Competence In order to be considered for this position, you must complete all required steps in the process. In addition to the application and application questionnaire, this position requires an online backssment. The online backssment measures critical general competencies required to perform the job.
The backssment includes a cut score based on the minimum level of required proficiency in these critical general competencies. You must meet or exceed the cut score to be considered. You will not be considered for the position if you score below the cut score or fail to complete the backssment. Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on the online backssment may also result in your removal from consideration. You will be placed in one of the following categories based on category rating and selection procedures if you meet all of the requirements outlined in this job opportunity announcement: Best Qualified - for those who are superior in the evaluation criteria Well Qualified - for those who excel in the evaluation criteria Qualified - for those who only meet the minimum qualification requirements If you are found to be among the top qualified candidates, you will be referred to the selecting official for employment consideration.
This is a competitive vacancy announcement advertised under Delegated Examining Authority. Selections made under this vacancy announcement will be processed as new appointments to the civil service.
Current civil service employees would therefore be given new appointments to the civil service; however, benefits, time served and all other Federal entitlements would remain the same. The category rating process does not add veterans' preference points or apply the " rule of three" but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Veterans' preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent will be listed in the highest quality category (except in the case of professional or scientific positions at the GS-09 level or higher).
Required Documents To apply for this position, you must submit a complete Application Package which includes: 1. Resume showing relevant experience; cover letter optional. Your resume must indicate your citizenship and if you are registered for Selective Service if you are a male born after 12/31/59. Your resume must also list your work experience and education (if applicable) including the start and end dates.
For work in the Federal service, you must include the series and grade level for the position(s). For resume and application tips visit:Your resume will be used to validate your responses to the backssment tool(s). We strongly encourage applicants to utilize the USAJOBS resume builder in the creation of resumes. Determining length of general or specialized experience is dependent on the information provided in the resume. Failure to include ALL of the information listed below on your resume WILL result in a finding of ineligible. Official Position Title (include series and grade if Federal job) Duties (be specific in describing your duties) Employer's name and address Supervisor name and phone number Start and end dates in the month year format (e.
g. June 2007 to April 2008) Full-time or part-time status (include hours worked per week) Salary 2. CMS Required Documents (e. g. SF-50, DD-214, SF-15, etc. ). Required documents may be necessary to be considered for this vacancy announcement.. Failure to provide the required documentation WILL result in an ineligible rating OR non-consideration.3. College Transcripts. Since this position requires specific education, you must submit a transcript attesting to your possession of the required education.
You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received. An official transcript is required if you are selected for the position. If selected, you must provide an original document before the final job offer may be extended. If you do not submit a transcript indicating your possession of the required education, you will not be considered for this position. College Transcripts and Foreign Education: Applicants who have completed part or all of their education outside of the U.
S. must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U. S. For a listing of services that can perform this evaluation, visit the website. This list, which may not be all inclusive, is for informational purposes only and does not imply any endorsement of any specific agency. If you are applying for a position for which a state license is issued (e. g. physician, engineer, attorney) possession of a valid and current U.
S. professional license by a graduate of a foreign professional school or program is sufficient proof that the foreign education has been determined to be equivalent to the requisite U. S. professional education in that occupational field.4. Reasonable Accommodation (RA) Requests: If you believe you have a disability (i. e. physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based backssments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based backssments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based backssments.
Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based backssments. You must complete all backssments within 48 hours of receiving the URL to access the USA Hire Competency Based backssments, if you received the link after the close of the announcement.
To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online backssments here: If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U. S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from. Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. PDN-9ad5cdb0-da68-40aa-b786-b38b4266b935
quant field (OR altern Master's in same fields + 3 yrs of exper in Quant & Alpha Research positions). Must have knwlge of: C, C++, Java or Python; machine learng algorms & ability to tweak them as needed; machine learng apps to real-world datasets; options datasets resrch; princpls of math, stat & financ modelg; time-series & large datasets analysis; parameters estimation using machine learng techniqs; math modelg incl.
analyt derivations & numer simulatns; stochastic procss; perturbation & harmonic analyses; statist inference & optimizatn; algorithms & numer methods; linear algebra & Partial Different Equatn numer solvers; options pricing theory & analyzg P&L, inventory & risks; C++
& Python (incl. Num Py, Sci Py, pandas, linear algebra & plotting pkgs); Linux, Bash & version control sysms; US stocks, ETFs, indices, futures, VIX futures & options traded on these underliers.
Must have published quant resrch in academic journals and/or presented at conferences (at least 3 papers). Must pass company's reqd skills assmt. Base pay: $165-$300k per yr (does not incl. other forms of compensation/benefits). Note Hybrid work attendance policy: In-office work reqd at below address on collab days based on each team's reqmt; remote work allowed rest of month. Send resume to xyz X@ or mail to TS/HR Dept, Two Sigma Investments, 100 6 Ave, 16 Fl, NY, NY 10013. Ref Job ID 12507. T Jobs. Category: , Keywords: Quantitative Researcher For more details: jobs-search. org/quantitative-researcher/quantitative-researcher-united-states_i1976632863
to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through
career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself.
Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities Clinical Research Project Plan and Preparation Review
of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources.
Prepares and maintains the Trial Master File (TMF) for the study. Participates in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings) Takes the lead and/or overall coordination of all required start-up activities including, but not limited, to the following: Clinic logistics planning, schedule of clinic activities, and team training Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules In collaboration with the responsible teams, establishes and/or maintains safety backssment requirements, Quality Control (QC) and monitoring plans, shop/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study.
Confirms all required regulatory and contractual documentation is present prior to study start. Clinical Conduct Coordinates and monitors screening activities; provides support as required. Coordinates and ensures set-up of clinic rooms, subject chart review, and source preparation prior to start of clinic activities.
Takes the lead and/or overall coordination of clinic activities including, but not limited to: Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable. Ensures volunteer eligibility prior to randomization; oversees or performs drug administration, and other activities as delegated and required. In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations.
Reviews and manages clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings. Post-Clinic/Close-Out Activities Coordinates resolution and/or address QC, monitor, CRF, or other internal/external findings Reviews and/or oversees close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation. Reviews and updates TMF documentation Finalizes study and/or volunteer logs. Ensures completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.
) Responsible for monitoring subjects' compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate. Prepares for and participates in sponsor/monitor/QA audits. Provides accurate and timely project status updates to Project Managers and sponsor. Collaborates within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company-related initiatives and goals. Accommodates flexible schedule (available days, afternoons, nights, and weekends).
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%). Qualifications What we're looking for University Degree such as R. N. or Bachelor of Science Degree. Clinical Research certification an asset. Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines. Good backssment, problem solving, planning, and evaluation skills. Possesses good time management, detail-oriented, and able to multi-task. Ability to provide clear and focused leadership. Good interpersonal and communication skills with a team focus. Knowledge of SOP writing. Ability to anticipate problems and provide solutions in a timely manner.
Ability to coordinate multiple clinical research projects with competing deadlines. Proficiency in computer software programs (e. g. Word, Excel, Power Point). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. PDN-9af5f656-014c-49d3-97ab-b5bf869c606d
regulatory science opportunities outlined in the FDA's Critical Path Initiative, we have forged global partnerships and created collaborations that include the FDA, European Medicines Agency (EMA), and Japan's medicals and Medical Devices Agency (PMDA) as well as private industry.
Our ongoing success is due to a combination of public and private support for our vision, as well as the dedicated team of employees that we have. Each and every employee is valued as a member of the team - they are much more than a number. We provide a great work environment that people love being a part of! POSITION OVERVIEW The Clinical Outcome backssment (COA) Scientist is responsible for assisting the COA
Program Vice President, PRO Consortium Executive Director, and other COA Program scientific staff in working with consortia/programs within Critical Path Institute (C-Path) to advance and document the development and/or evaluation of PRO measures and other COAs for use in drug development where COA-based endpoints are used to support the evaluation of clinical benefit.
SUPERVISORY RESPONSIBILITIES None CORE DUTIES/RESPONSIBILILITIES Serve as scientific lead for select therapeutic area working groups within the PRO Consortium Provide scientific input/expertise to selected project teams during all stages of the COA development, evaluation, and/or regulatory review and endorsement processes
(e. g. qualification) Assist with selecting, managing, and/or collaboratively working with outside vendors engaged to help accomplish specific project goals Lead or participate in the generation and execution of analysis plans for the quantitative evaluation of COAs Participate in the preparation of grant applications for targeted funding opportunities Participate in the development and presentation of educational/training activities within C-Path and beyond Lead and/or participate in writing teams focused on disseminating scientific achievements/advances in peer-reviewed journals and other scientific venues Review and provide critical/constructive feedback on vendor deliverables Lead or participate in the preparation of formal documents for submission to regulatory agencies Represent C-Path at national and international scientific and regulatory meetings Other duties and responsibilities as assigned REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Excellent oral, written, and virtual communication skills Able to lead the writing of manuscripts for publication in peer-reviewed journals from inception to acceptance (If not on resume/CV, please provide a list of your publications in your cover letter.
) Knowledge of FDA and EMA regulations, requirements, and expectations regarding clinical trial efficacy endpoints, particularly COA-based endpoints Thorough understanding and experience in the development and evaluation of COAs (e.
g. PRO measures, observer-reported outcome [Obs RO] measures, clinician-reported outcome [Clin RO] measures, performance outcome [Perf O] measures) Proficiency in R and J Metrik is preferred Strategic planning and leadership skills Effective management, interpersonal, negotiation, time management, and problem-solving skills Able to productively engage in complex, multi-stakeholder collaborations and research teams Able to meet target deadlines and manage time effectively Able to identify opportunities for improvement, make constructive suggestions for change, and operationalize those within the team Demonstrates sound business judgment when making decisions and adheres to external and internal policies and regulations Strong critical thinking and analytical skills (Please provide specific examples in your cover letter.
) Able to successfully anticipate issues or challenges and proactively address without being specifically directed Sound judgment when working with critical or confidential information Proficient in the use of Microsoft Office Suite: Word, Excel, Power Point, Outlook REQUIRED EDUCATION AND EXPERIENCE A Ph D (or equivalent doctoral degree) is preferred in Health Outcomes, Psychology, Public Health, Psychometrics, Epidemiology, Biostatistics, or related scientific discipline A minimum of five years' experience in health outcomes research and, specifically, in the qualitative and quantitative components of ensuring valid and reliable backssment of clinical benefit in drug treatment trials A firm grasp of the medical/biotechnology industry, FDA, EMA, and the healthcare environment Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of medical products COVID-19 In accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, C-Path has adopted a policy to comply with this requirement.
All C-Path employees must be vaccinated to safeguard the health of our employees and their families; and the community at large from COVID-19. Reasonable Accommodation Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible.
Accommodations will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department. Critical Path Institute is an equal opportunity employer. Visit our website at www. c-path. org The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills.
Other duties ay be added, or this description amended at any time. Job Posted by Applicant Pro
package. The Research Assistant will provide research services and support compatible with the Clinical Investigations Facility 60th MDG operating capacity and equipment and will provide assistance to the Clinical Research Manager, Principal Investigator(s) (PI), and Clinical Research Coordinators to facilitate biomedical human and animal research protocols.
The Research Assistant shall assist the Clinical Research Manager with the following in order to develop research protocols: Identify the appropriate forms and processes necessary to complete the research protocol. Coordinate statistical and scientific consultation from CIF staff. iii. Facilitate review and approval of the research
protocol. At the direction of the Clinical Research Manager, the Research Assistant shall assist with coordinating assigned research studies in accordance with approved protocol and applicable local and state and federal regulations while promoting the safety and confidentiality of research subjects and their data at all times: Ensure study materials, equipment and/or research animals are ordered for the research protocol and in accordance with Clinical Research Division policies.
Maintain complete and accurate drug and equipment accountability at all times. iii. Advertise the study and recruit participants. Meet with potential research subjects to explain the research project in detail
and enroll eligible subjects into the study by obtaining written informed consent.
Schedule subjects for a research appointment(s) or schedule operating room time. Maintain a master calendar for the study, and serve as point of contact for research subjects. vii. Identify delays and other shortcomings in meeting objectives and develop acontingency plan as required. viii. Administer surveys or questionnaires. Deliver specimens to internal laboratory and/or shipping specimens to a referral laboratory. Collect clinical samples and/or data within their scope of practice. Abstract required research data elements from paper or electronic patient records or other existing documents or files, in accordance with an approved research protocol and enter these data in the spreadsheets, databases, and/or statistics software.
xii. Work with the primary investigator and/or statistician to refine and prepare data sets for analysis. The Research Assistant shall provide administrative support for the management of clinical research operations as necessary: Assist with IRB and/or IACUC agenda and minutes preparation. Maintain electronic and paper files of research protocols in accordance with regulatory requirements. iii. Coordinate administrative tasks (scheduling, room reservations, etc.
) to support research educational programs. Must submit a monthly status report to TMG. Research Assistant Required Knowledge, Skills, and Abilities: Ability to communicate effectively, both orally and in writing. Knowledge of Medical Treatment Facility (MTF) Infection Control and Employee Health Programs. Skilled in the use of word processing, spreadsheet, graphic, email, and database software. Skilled in writing memorandums, correspondence, abstracts, articles, and proposals. Ability to plan and prioritize work. Ability to exercise independent judgment in the resolution of problems.
Ability to make presentation to groups. Ability to be a selfstarter and work independently. Ability to interface with investigators, vendors, research staff, and study participants. Minimum Education/Training/Experience Requirements: Possess, at minimum, an Associates' degree in a health related field (for example, nursing, shop, biology, health scientist or public health specialist) or a clinical certification (for example, certified nursing assistant or laboratory technician). One to Two years of clinical experience within the past three years, preferably in the research setting.
Experience in providing assistance to the Principal Investigator(s) (PI) to facilitate biomedical human and animal research protocols. Possess current certification in Basic Life Support (BLS). The contractor/clinical research assistant is responsible for maintaining the certification in a current status throughout the life of this contract. Job Posted by Applicant Pro