Clinical Research Coordinator A (OBGYN - GYN Ocology)

Job Description Summary

Clinical Research Coordinators in the Division of GYN Oncology support multiple externally funded investigator initiated and cooperative group clinical trials. The CRC will be responsible for patient screening, subject enrollment, scheduling, collecting, storing and shipping biological samples; collecting and filing study documents; and collecting and entering clinical data. Utilizing a variety of electronic systems, the CRC will document study activities with accuracy. The coordinator may assist with Institutional Review Board (IRB) filings and inquiries and with manuscript preparation, grant proposals, and research related presentations. The CRC will oversee 2 or more clinical trials, ensuring that the protocol integrity is maintained, all data and queries are answered in a timely manner, and AEs and SAEs are appropriately reported to the sponsor and IRB per protocol. In addition to the responsibilities mentioned above, The CRC will take an active role in preparation of trial audits and inspections. The CRC will assist with mentoring research assistants.

Job 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.
• Oversee study preparation and blood sample processing and analysis
• 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

Position contingent upon continued funding

Qualifications

Position requires a highly motivated, articulate individual with excellent oral and written communication skills. The candidate should possess the ability to work independently and also as part of a team. Strong planning, organizational and prioritizing capabilities along with problem solving skills desired.

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$46,500.00 - $46,500.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.