Clinical Research Coordinator - VRC

EOE Statement
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.

About the Organization
Wills Eye Hospital, located in Philadelphia, Pennsylvania, is a global leader in the treatment of eye disease. Established in 1832 as the America's first eye hospital, we are one of the world's premier eye care facilities and the #2 best hospital in the nation for ophthalmology as ranked by U.S. News & World Report.

Our clinical expertise, state-of-the-art diagnostic testing and advanced surgical capabilities make Wills Eye a worldwide referral center where more than 250,000 patients are treated annually. From common eye problems to rare sight-threatening diseases, Wills Eye provides general eye care and comprehensive ophthalmic specialty services that attract patients throughout the Philadelphia metropolitan area, across the country and around the world.

Today, we continue to shape the science and medicine of ophthalmology, thanks to our talented, skilled physicians and staff who are dedicated to improving and preserving sight.

Description

Primary Function:

Under general supervision of the Principal Investigator and Vice Chair for Research/Director- Vickie and Jack Farber Vision Research Center, manages complex clinical trials in accordance with FDA GCP guidelines.

Essential Duties and Responsibilities:

1. Responsible for overall coordination of site-specific clinical trial activities.
2. Responsible for maintaining ongoing communication with the study team, sponsor, CROs, other relevant entities at Wills, (e.g. IRB, Director of Sponsored Projects, finance) and study subcontractors, including scheduling routine study team meetings.
3. Manages and participates in all aspects of sponsored clinical trial preparation, start up and implementation, including obtaining informed patient consents, patient screenings for eligibility, enrolling/monitoring study patients in an outpatient setting, and ensuring protocol compliance.
4. Reviews protocols with PI and makes all necessary preparations for the study.
5. Schedules subject visits and any necessary testing.
6. Monitor subjects per protocol requirements and ensure adherence to all protocol requirements.
7. Assists with preparation and filing of Institutional Review Board (IRB) applications and responses to inquiries.
8. Organizes and maintains complete and accurate study documentation, including regulatory binders, and all documentation required by the sponsor including source documentation, case report forms, and research charts.
9. Responsible for all documenting, adverse events reporting, and maintenance of regulatory files with accuracy and timeliness.
10. Collects, reviews and reports study data to the sponsor, completes case report forms and submits to EDC, resolves data queries, processes and ships study specimens including blood and tissue samples.
11. Documents all communications between patients, investigators, monitors and sponsor related to specific study and files with CRF, subject source document and regulatory binder.
12. Works closely with the Principal Investigator, Vice Chair for Research and study team to identify problems relating to study conduct (e.g., recruitment, follow-up and staffing) and develop solutions. Implement approved changes to procedures as needed and monitor results.
13. Schedules, assists in preparing for and participates in on-site visits with the sponsor, including initiation, monitoring, audit and close-out visits.
14. Schedules and participates in study team meetings and ongoing protocol training/compliance meetings.
15. Ensures patient safety, protocol compliance and data quality.
16. Serves as a liaison between the patient, investigator, IRB and study sponsor in an effective and timely manner.
17. Closes the study with the sponsor and stores study records appropriately.
18. Applies knowledge of regulatory processes including Institutional Review Board (IRB), Good Clinical Practice (GCP) to all aspects of study conduct.
19. Adheres to all hospital, FDA and GCP guidelines.

Position Requirements

Qualifications:

Educational requirements:

• Bachelor's degree and 4-5 years of related experience or equivalent combination of education and experience

Licensure/Certification:

• CCRP or CRA certification preferred.

Skills & Attributes:

• Knowledge of FDA and IRB requirements for drug and device research protocols.
• Experience with investigational drug and device studies
• Effective verbal and written communication skills and strong analytical, organizational and interpersonal skills.
• Ability to work within a team environment as well as independently.
• Commitment to continuous learning as required.
• Ability to make decisions independently.
• Ability to manage time, multi task and prioritize work.
• Ability to identify, analyze and solve problems; ability to work well under pressure; knowledge of IRB and human research protection regulations.
• Exhibits a cooperative attitude toward patients, co-workers, and investigators.
• Maintains a professional appearance and professional work environment
• Effectively communicates on appropriate information on project status, unresolved problems and issues involving departments and companies.
• Displays willingness to assist co-workers in the interest of meeting group goals.
• Ophthalmic experience preferred.

Category
Research

Full-Time/Part-Time
Full-Time

Position
Clinical Research Coordinator - VRC

Number of Openings
1

Exempt/Non-Exempt
Exempt

Location
Wills Eye Hospital

This position is currently accepting applications.