Clinical Research Coordinator C

University of Pennsylvania Perelman School of Medicine

6d • $63,085 - $67,046 • Onsite

About The Position

This position will be a resource for best practices of managing major clinical trials. The coordinator will be responsible for managing both study drug trials and device trials, as applicable. They will collaborate with internal study teams, nursing units, and sponsors, working to efficiently run all phases of clinical trials. They will be a resource to other members of the team, helping to train newer staff members, identify and problem solve challenges in study management and site standard operating procedures (SOPs), and will oversee and assist with the implementation of new trials.

Requirements

• Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
• Excellent verbal/written communication skills required.
• Able to work collaboratively on all levels and to gain support of others.
• Able to confidently interact with all levels of management including senior management, physician leaders and others.
• Demonstrated complex problem solving abilities.
• Strong innovative skills.
• Excellent interpersonal and multi-tasking skills.
• Must be flexible, detail oriented, and organized.
• Demonstrated ability to work as part of a team, as well as independently with minimal supervision.
• Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines.

Nice To Haves

• Knowledge of funding policies, NIH, and other grant procedures is desired.

Responsibilities

• Function as lead coordinator on several complex phase I-IV studies.
• Maintain protocol compliance, enrollment and retention of subjects, management of subject visits, management of study drug or devices, and regulatory submissions.
• Recruit, consent, and screen patients into the protocol.
• Schedule subject visits.
• Monitor and ensure adherence to protocol requirements.
• Train subjects on study procedures and devices.
• Maintain organized study documentation including source documents, case report forms, subject binders, regulatory binders, and electronic data entry.
• Collect, review, and report study data, complete data entry, and resolve queries.
• Manage all aspects of subject visits including subject training and retention, completion of assessments and questionnaires (PROs), and collection, processing, and shipping of laboratory samples.
• Perform assessments which may include ECG/EKGs, vital sign collection, cognitive testing, training subjects on study devices or programs, review of medications and medical history, review and reporting of adverse events.
• Participate in study start up, ongoing study maintenance, monitoring, audits, and close out visits.
• Attend study team meetings and ongoing protocol training or compliance meetings.
• Develop and maintain study specific source documents, regulatory submissions, and regulatory documents/binders.
• Review internal budgets, complete research billing, invoice the sponsor, and set up subject payments per budget.

Benefits

• Excellent healthcare and tuition benefits for employees and their families
• Generous retirement benefits
• A wide variety of professional development opportunities
• Supportive work and family benefits
• A wealth of health and wellness programs and resources
• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
• Flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
• Tuition assistance for employee, spouse, and dependent children
• Generous retirement plans (Basic, Matching, and Supplemental)
• Substantial amount of time away from work
• Long-Term Care Insurance
• Wellness and Work-life Resources
• Professional and Personal Development resources
• Access to a wide range of University resources as well as cultural and recreational activities
• Discounts on arts and entertainment, transportation, and mortgages
• Flexible work options
• Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
• Adoption Assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level