Quantitative researcher | Alabaster, AL

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

of the Principal Investigator (PI). The CRC may be involved in the coordination and administration of FDA-regulated clinical trials (Phase 2-4), other sponsored studies or registries, and investigator-initiated studies related to urologic care, especially in the areas of urinary incontinence and cancer of the prostate, bladder, and kidney.

The CRC must be able to effectively coordinate multiple studies concurrently and appropriately prioritize tasks across assigned studies and responsibilities. Primary responsibilities : Study preparation and planning Regular, timely communication with study stakeholders Acquiring and filing/maintaining regulatory documents and other documentation Patient

recruitment, prescreening, and consenting Tracking of study- and patient-related information and status in spreadsheets/databases. Maintenance and tracking of supplies, equipment, and investigational products/devices/drugs Study visit coordination and data collection Data entry and query resolution Monitoring visit coordination and follow-up Study closeout Essential skills: High level of integrity/ethical standards with special attention to confidentiality and compliance Demonstrate professional conduct and exercise sound judgment Possess strong interpersonal and communications skills, both verbal and written, with the ability to communicate appropriately and effectively with multiple internal

and external stakeholders Read and comprehend clinical, technical, and regulatory information (e.

g. clinical study protocol) Strong attention to detail, schedules, and timelines Multi-task and prioritize work tasks and projects and work efficiently in a busy work environment Readily use technology and electronic computer systems effectively in performing day-to-day tasks; including but not limited to using Microsoft Outlook, Word, Excel and Power Point, databases, and electronic data capture systems (EDCs) Work independently with minimal supervision once orientation and essential general training requirements are completed Actively investigate issues and make best effort to independently troubleshoot problems related to job responsibilities when appropriate Ability to work well in a team environment QUALIFICATIONS: Bachelor's degree is highly preferred.

A degree related to the health/medical or biological science field is highly preferred. Current (non-expired) Good Clinical Practice (GCP) training documentation is preferred. Current GCP training with FDA-focus required within the first 2 weeks of hire. Certification in clinical research (e. g. CCRC, CCRP, or CRA) is preferred. Relevant Experience Minimum of three years of full-time experience or equivalent: Biomedical or clinical research Clinical care or laboratory medicine (e.

g. MA, LPN, RN, MLT) Research or clinical/healthcare administration Partial years and/or part-time experience may be added together to a total of 3 years. Having an advanced degree in a health- or science-related field will qualify as one year of experience. Clinical research coordinator experience is highly preferred. Prior experience working within an electronic medical record (EMR) system is highly preferred. Minnesota Urology P. A. is an equal opportunity employer. Job Posted by Applicant Pro