CLINICAL RESEARCH COORD C
Duties: The primary responsibility of the Clinical Research Coordinator C position is to independently coordinate Phase I- IV and observational clinical trials at Penn and other multiple sub-sites across the country. The ideal candidate for this position will have the ability to handle a variety of clinical trial related responsibilities in accordance with University of Pennsylvania, GCP, and FDA guidelines and oversee the performance of external sub-sites. In addition this person should have excellent communication skills, experience managing multi-site studies, and is able to work independently with minimal supervision.
The responsibilities of the Clinical Research Coordinator C include but are not limited to:
* Prepares and submits required study documentation to Institutional Review Boards (IRB) including initial submissions, continuing reviews, amendments, deviations, exceptions, and adverse event reporting.
* Prepares and maintains assigned external study site regulatory documentation
* Organizes and maintains assigned site documentation required by sponsor and institution (1572s, reliance agreements, training certifications, institutional forms, FDA forms, deviation and exception memos, etc.).
* Develop and implement recruitment tracking methods for 40-50 study sites.
* Provide guidance and assistance to study sites on recruitment and enrollment efforts.
* Monitor enrollment milestones and create and present reports to research team, lead investigators, and study sponsors.
* Develop plans and systems to oversee dosing protocol compliance, data collection, and adverse event reporting at 40-50 study sites.
* Lead the drafting and maintenance of study guidance tools and documentation (e.g. CRFs, MOPs, lab manual, workflows, data management plans, data system SOPs, etc.) and coordinate the efforts of junior CRCs for review, revision, and distribution of documents.
* Participates in the necessary financial aspects of site and subject participation, including site subaward and budget development and monitoring, invoice processing, reviewing billing of research procedures in electronic systems, and tracking of participant compensation.
* Plans and implements the initiation, monitoring and closeout visits with sponsors and other study sites
* Communicate monitoring findings with external study sites through discrepancy resolution
* Supports and interacts with principal and subinvestigators
* Attends study related meetings and conferences
* Effectively communicates with all team members, other departments , and external study sites
* Adheres to all University of Pennsylvania, GCP, and FDA guidelines
* Perform additional duties as assigned
Qualifications: Bachelor's degree and 4 to 6 yrs of experience or a combination of education and experience required. Master's degree preferred. At least 3-5 years of experience in clinical research or the equivalent . Knowledge of IRB and Human Research Protection Regulations. Experience working directly with patients required.
Experience managing external study sites strongly preferred. Demonstrated ability to follow detailed clinical research protocols. Excellent communication and interpersonal skills. Excellent organization skills and demonstrated attention-to-detail and timelines. Ability to work independently with minimal supervision. Ability to multi-task and be flexible in both task and schedule.
Reference Number: 40-28142
Salary Grade: 027
Employment Type: Exempt
Job Family: I-Technical/Professional Research