University of Pennsylvania→
Clinical Research Coordinator A (Affective… at University of… · 3535…
Entry LevelOn-siteFull-time3535 Market$46k–$47k/yr
Skills
clinical trials coordinationpatient recruitmentinformed consentchart maintenancedata entryirb submissionsfda guidelines complianceregulatory compliancebiological sample collectiondatabase managementclinical data collectionclinical practicehuman subject protectionsleep study equipment setup
Job Description
Summary: The University of Pennsylvania, a prestigious Ivy League institution and the largest private employer in Philadelphia, is seeking a Clinical Research Coordinator A for its Affective Disorders Program. This role involves managing and collecting data for clinical trials, coordinating patient screening and enrollment, and ensuring compliance with regulatory requirements while working closely with the research team.
Responsibilities:
- Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry
- Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines
- Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations
- Be primarily responsible for traveling to participants' homes in the evening to set up equipment for sleep studies, and return in the morning to pick up equipment. Must have a personal vehicle for this purpose. Mileage will be reimbursed
- Database management and analysis
- Ordering and stocking supplies, maintaining equipment
- Educate patients and family members
- Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
- Other duties and responsibilities as assigned
Required Qualifications:
- Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required
Required Skills: Clinical Trials Coordination, Patient Recruitment, Informed Consent, Chart Maintenance, Data Entry, IRB Submissions, FDA Guidelines Compliance, Regulatory Compliance, Biological Sample Collection, Database Management, Clinical Data Collection, Clinical Practice, Human Subject Protection, Sleep Study Equipment Setup
Benefits: Health, Life, and Flexible Spending Accounts, Tuition, Retirement, Time Away from Work, Long-Term Care Insurance, Wellness and Work-life Resources, Professional and Personal Development, University Resources, Discounts and Special Services, Flexible Work Hours, Penn Home Ownership Services, Adoption Assistance
Benefits
Health, Life, and Flexible Spending Accounts
Tuition
Retirement
Time Away from Work
Long-Term Care Insurance
Wellness and Work-life Resources
Professional and Personal Development
University Resources
Discounts and Special Services
Flexible Work Hours
Penn Home Ownership Services
Adoption Assistance