Clinical Research Assistant I - Human Genetics | Philadelphia, PA

Research & Development (R&D) jobs involve creating new products or improving existing ones through innovative processes. Professionals in these roles conduct experiments, analyze data, and turn concepts into practical solutions. R&D is pivotal in industries such as pharmaceuticals, technology, and engineering, and is characterized by a focus on innovation, problem-solving, and continuous learning. R&D positions often require advanced education and a strong foundation in scientific or technical disciplines. These roles are essential for driving progress and maintaining competitive edges in marketplaces.

and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career. CHOP's Commitment to Diversity, Equity, and Inclusion CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace.

We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage all candidates of diverse backgrounds and lived

experiences to apply. A Brief Overview This is a full-time position offered through Clinical Futures at the Children's Hospital of Philadelphia. Under minimal supervision, a CRC I will coordinate all clinical research activities within the scope of clinical research protocols.

This research coordinator will support Dr. Emily Gregory's research projects. Dr. Gregory's research focuses on the role of pediatric primary care settings in supporting mother-infant dyads after high-risk pregnancies, with a goal of improving pregnancy outcomes and long-term health for families. Her primary project is a pilot clinical trial of dyad care coordination for mother-infant dyads after preterm birth.

The research coordinator will support this project by managing recruitment, consent, and enrollment activities, coordinating with participants around study data collection, maintaining the study database, and activities related to reporting to the IRB and the funder.

The research coordinator will also assist with data management and analysis for several secondary data projects, using data sources such as Medicaid claims and electronic health record data. The ideal candidate will have Master's Degree in a health-related field, experience using Stata, SAS, R or equivalent biostatistical software and prior research experience. The ideal candidate should also have experience with diverse low-income urban families through prior work, volunteer, or other experience a strong interest in and commitment to maternal child health research and policy that aims to improve outcomes for children and families.

What you will do Core responsibilities Adhere to an IRB approved protocol Participate in the informed consent process of study subjects Support the safety of clinical research patients/research participants Coordinate protocol related research procedures, study visits, and follow-up care Screen, recruit and enroll patients/research participants Maintain study source documents Under the supervision of PI Report adverse events Understand good clinical practice (GCP) and regulatory compliance Educate subjects and family on protocol, study intervention, etc.

Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials Must comply with federal, state, and sponsor policies For multi-site studies or collaborations, support communication and meeting scheduling across teams Related responsibilities Manage essential regulatory documents Register study on Clinical Trials. gov as appropriate Complete case report forms (paper & electronic data capture) and address queries Submit documents to regulatory authorities (e.

g. IRB, FDA, etc. ) and/or review/monitoring boards (ie, DSMB, independent safety officer) Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate Facilitate study close out activities as appropriate Coordinate research/project team meetings Collect, process and ship samples as applicable to the protocol Schedule subject visits and procedures Retain records/archive documents after study close out Education Qualifications High School Diploma / GED Required Bachelor's Degree Preferred Experience Qualifications At least two (2) years of clinical or clinical related or research related experience Required At least three (3) years of clinical or clinical related or research related experience Preferred Skills and Abilities Basic knowledge of IRB and human subject protection Strong verbal and written communications skills Strong time management skills Ability to collaborate with stakeholders at all levels To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community.

As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more. Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed. EEO / VEVRAA Federal Contractor Tobacco Statement

New Hires will be required to send Human Resources proof that they have received both Covid-19 vaccination doses (except for the one shot Johnson & Johnson vaccine) prior to their start date. Job Description The primary responsibility of the Research Assistant is to assist the Research Unit in conducting clinical trials.

The Research Assistant is responsible for collecting and processing clinical data and providing administrative support to the Research Team. Essential Functions Assists the Research Coordinator in the conduction of clinical trials and patient flow. Adequately and correctly collects clinical data on research patients and utilizes for data entry. Assists Coordinator with

monitor preparation and follows up on any action items and query resolution. Assists in recruitment (chart reviews, communicating with Physicians, database reports).

Aides in regulatory submissions and assists Regulatory Specialist as needed. Assists Fellows and Physicians on research projects and data collection. Maintain temperature logs for drug closet, freezer and refrigerator. Reports any deviations. Checks and replaces batteries as needed. Performs administrative duties for Research Unit including answering phones, scheduling appointments, and ordering supplies. Screens research subjects with Coordinator assistance. Regular and predictable on-site attendance required. Works overtime

as needed. Travels to other MAR locations as needed. Performs other duties as assigned.

Competencies Communication & Relationship Management - Maintains open and interactive discussion with team and is aware of their needs. Professionalism - Develops individual relationships with coworkers and reports while maintaining work appropriate boundaries. Customer Service - Conflict resolution skills, responds promptly to customer needs. Project Management - Strong organization, multi-tasking skills with great attentiveness to detail. Ability to prioritize responsibilities. Technical Skills - Knowledge of health care and medical procedures, including terminology.

Knowledge of vision/retina/ophthalmic terminology and procedures Problem Solving/Analysis - Identify and resolve problems and conflicts promptly Ethical Conduct - Maintains confidentiality. Time Management - Maintains high volume productivity level for essential functions. Supervisory Responsibility This position has no direct supervisory responsibilities. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk/communicate verbally in front of groups, one to one and over the telephone and in email. Occasional bending, kneeling, stooping, and crouching. Lift or move objects weighing over 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Using hands to operate equipment, show manual or finger dexterity, handle things with precision or speed, use muscular coordination and physical stamina.

Use senses to observe and examine patients, paying attention to detail/working with data and numbers, calculating and manipulating numbers, processing data on a computer, attending to details, classifying, and recording, storing or retrieving information. Following through on plans or instructions. Position Type/Expected Hours of Work This is a full-time position. Occasional evening and weekend work may be required as job duties demand. Travel Willingness to travel is required.

Required Education and Experience 1 year clinical research experience or ophthalmic experience. EEO Statement MAR is a proud Equal Opportunity Employer. Job Posted by Applicant Pro

relevant collaborative projects.

Under the supervision of the Clinical Research Project Manager, the CSRACRAS II will follow established policies and procedures. The CSRACRAS II may be responsible for the following activities including recruiting and evaluating subjects for studies; collecting and managing data; scheduling research sessions and meetings; consenting participants; collecting research data; developing study materials and databases; supporting data analysis; tracking academic productivity; assisting with the training and onboarding of multicenter sites; preparing, writing, and submitting research grants, manuscripts, and IRB protocols.

The CSRA II will support Clinical

Research Project Manager to organize the study enrollment, data summary, task management, and organization of the meetings. The CSRA II will use Outlook, Microsoft Word, Powerpoint, Excel, REDCap, and other data management software/website.

Basic knowledge in human subject protection and Institutional Review Board practice are required. The CSRA II may need to be flexible for the work hours to meet the needs and requirements of the research procedure. Essential Functions Providing technical and clinical support in the conduct of clinical studies: Filing and office organization Patient/research participant scheduling Patient/research participant history Data collection Data entry

Data management Laboratory procedures Follow-up care Order materials/supplies Schedule research meetings Take meeting notes and summarize minutes Facilitate communication through protected institutional emails Research Study Compliance Adhere to an IRB approved protocols Comply with Institutional policies, SOPs and guidelines Comply with federal, state, and sponsor policies Also may be responsible for any of the following: Participate in the informed consent process for study subjects Document and report adverse events Maintain study source documents Submit basic IRB reports Complete case report forms (paper and electronic data capture) Maintain and update the research enrollment logs Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives.

Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career. CHOP's Commitment to Diversity, Equity, and Inclusion CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace.

We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage all candidates of diverse backgrounds and lived experiences to apply. A Brief Overview Under the direct supervision of the study team, assists in the coordination of the details of the human research subject study and documentation concerning study protocols.

What you will do Providing technical and clinical support in the conduct of clinical studies: Filing and office organization Patient/research participant scheduling Patient/research participant history Data collection Data entry Data management Laboratory procedures Follow-up care Order materials/supplies Schedule research meetings Research Study Compliance Adhere to an IRB approved protocols Comply with Institutional policies, SOPs and guidelines Comply with federal, state, and sponsor policies Also may be responsible for any of the following: Participate in the informed consent process for study subjects Document and report adverse events Maintain study source documents Submit basic IRB reports Complete case report forms (paper and electronic data capture) Education Qualifications Associate's Degree Required Bachelor's Degree Preferred Experience Qualifications At least two (2) years relevant clinical research experience.

Required Skills and Abilities Basic knowledge of IRB and human subject protection. To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community.

As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more. Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed. EEO / VEVRAA Federal Contractor Tobacco Statement