Clinical Research Coordinator I

The Philadelphia Research and Education Foundation (PREF) is a 501 (c) 3 nonprofit that supports the research and teaching mission of the Corporal Michael J. Cresencz (CMC) VA Medical Center. PREF is hiring a Clinical Research Coordinator I (RC). This position reports to the Principle Investigator and the Executive Director of PREF. Interaction with senior medical center management and staff, affiliated university staff and VA employees is also required of this position. In addition to the criteria listed below, the ideal candidate will be a highly motivated, fast learner and that is willing to work hard to further develop the research program. The research focus of the coordinator's team will be in hepatology. The teams area of study is how to better treat and prevent liver cirrhosis. The coordinator will primarily be working in data abstraction from the VA electronic medical record (EMR) database as well as screening for the team's studies.

Major Duties: The Clinical Research Coordinator will plan and perform research and administrative tasks for various studies, including:

• Assist in preparation of clinical protocols
• Prescreen patients according to study protocols
• Organize and help maintain study documentation, includes source documentation, case report forms, research charts, and study logs
• Prepare for study visits including labeling and creating visit packets
• Collect and review study data
• Participate in study team meetings, and ongoing protocol training
• Perform general administrative duties such as patient disbursements, filing, etc.
• Develop study specific source documents and trackers, input data, help prepare regulatory submissions, and help with study start up activities
• Participate in study monitor visits
• Performs other related duties as assigned

MINIMUM QUALIFICATIONS:

Education: Bachelor's degree in nursing, chemistry, biology, public health, psychology or another scientific discipline appropriate to position preferred.

Experience: Prior VA, clinical research, and/or data experience is preferred.

Other Requirements:

• Detail oriented
• Willingness and ability to manage studies
• Experience working with medical terminology
• Experience submitting regulatory documents
• Advanced MS Office skills to include MS Word, PowerPoint, and Excel
• Must have strong verbal and written communication skills
• Must maintain databases and other supporting files critical to the operations, management, and financial reporting of the studies
• Advanced critical thinking skills
• Must be able to maintain confidentiality of information and records
• Willing to do the large and small tasks necessary to support a clinical trial center

RESPONSIBILITIES/DUTIES

Screen, recruit, and consent patents according to GCP and study protocol. Maintain study documents for enrollment and data storage. Estimated 5% of work time.

Schedule patients for study visits and meet with patients to perform necessary visit and study protocol requirements. Perform necessary research data entry. Estimated 2.5% of work time.

Prepare and process Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments, and adverse event reporting. Prepare, process, and organize all regulatory documentation. Work with federal or private sponsors, and clinical research organizations (CROs). Estimated 2.5% of work time.

Promptly communicate with study site investigators and the research team to fulfill study commitments and contract requirements. ~2.5%

Supervise other coordinators working with the investigator and ensure that the research team is updated and provided with the most current data regarding patient enrollment and study procedures. ~2.5%

Participate in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. ~5%

Facilitate conference calls and team communications when necessary. ~2.5%

Perform additional duties as assigned. ~2.5%

Chart abstraction and entry of data in REDCAP or other case report form for data analysis. ~70%

Analysis of abstracted data and preparation of research data for presentation. ~5%

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in Philadelphia, PA 19104

Salary : $48,985 - $63,841