Casual Compliance Support Officer
Jhpiego
Support Jhpiego’s U.S. government compliance program through risk tracking, document control, training, and reporting. Remote position based in Baltimore, Maryland.
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The University of Pennsylvania Perelman School of Medicine combines medical education, healthcare research, and patient care within the University of Pennsylvania. Its work spans the training of future healthcare professionals and efforts to advance medical knowledge, creating opportunities for people working across education, healthcare, research, and nonprofit settings.
Clinical Research Coordinator
Coordinate participant visits, study protocols, IRB submissions, and clinical data for the University of Pennsylvania’s medical research programs.
Description
- Conduct participant visits in homes and at study sites.
- Provide participants with study incentives and recruitment materials.
- Speak with potential participants to gauge their interest in research.
- Explain consent procedures to participants verbally.
- Carry out study protocols.
- Review and synthesize relevant literature.
- Help code interview data.
- Prepare and process IRB submissions, amendments, continuing reviews, and adverse event and serious adverse event reports.
- Organize and maintain sponsor or CRO records, including case report forms, source documents, study and regulatory binders, and subject binders.
- Oversee data entry in study datasets.
- Prepare manuscripts and research findings for presentation.
- Support the administrative needs of research operations.
- Attend weekly study progress meetings with the PI and research team.
- Travel between study visits.
- Take on other duties as assigned.
Requirements
- A Bachelor of Science and 2 to 3 years of experience, or an equivalent combination of education and experience.
- Knowledge of federal regulations and guidance for clinical studies and human subject protection.
- Ability to manage IRB submissions and renewals in line with FDA and IRB guidelines.
- Ability to ensure compliance with study protocols and regulatory requirements.
- Ability to collect, record, and maintain data and source documents.
- Follow University of Pennsylvania, ICF, FDA, and NIH guidelines and policies.
- Background checks may be required after a conditional job offer.
Benefits
- Medical, prescription, behavioral health, dental, vision, and life insurance coverage.
- Pre-tax flexible spending accounts for eligible health care and dependent care expenses.
- Tuition assistance for employees, spouses, and dependent children at Penn, and for dependent children at other institutions.
- Basic, matching, and supplemental retirement plans with pre-tax or Roth options.
- Substantial time off for vacation, personal matters, illness, injury, and family time.
- Long-term care insurance.
- Wellness and work-life programs and resources.
- Resources for professional and personal development.
- Access to University libraries, athletic facilities, arboretum, art galleries, and cultural and recreational activities.
- Discounts and special services for arts and entertainment, transportation, mortgages, cars, cellular plans, movie tickets, and theme parks.
- Flexible work hours and work options.
- Forgivable homeownership loan for eligible employees in West Philadelphia.
- Adoption assistance for qualified expenses, covering up to two adoptions per household.
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