CLINICAL RESEARCH COORD C
Duties: The responsibilities of the Clinical Research Coordinator C include but are not limited to:
* The preparation and processing of all Institutional Review Board (IRB) documentation through the IRB for Sponsor Initiated Studies as well as Investigator Initiated, including submissions, continuing reviews, amendments and adverse event reporting.
* The recruitment, screening, and enrollment of all study subjects including all documentation of these activities.
* The ability to develop appropriate study specific documents and study tools to enable the proper and compliant execution of any initiated studies including but not limited to Case Report Forms, completion guideline, operations manuals, data management plans, standard operational procedures, workflow processes.
* Ability to obtain and process study specimens in accordance with regulations and study protocol.
* Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation and exception memos, physicians and coordinators' CVs and medical licenses, record of IRB certification and compliance).
* Work directly with principal investigators and other coordinators as needed for the successful execution of the clinical trials.
* Prepare and process all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs).
* Assist in the orientation and training of new coordinators.
* Adhere to all University of Pennsylvania, GCP, and FDA guidelines.
Qualifications: The qualifications necessary for the Clinical Research Coordinator C position include:
* Minimum of a BS/BA or BSN and 4-6 years experience in direct human subjects research or an equivalent combination of education and experience.
* Knowledge of IRB and Human Research Protection Regulations
* Should be comfortable doing a variety of tasks, be able to balance multiple commitments, and be proficient at adaptive multi-tasking.
* Must be extremely dependable, able to meet deadlines, self-motivated, and highly efficient.
* Should demonstrate interest in the work, a strong work ethic, and personal and professional integrity.
* Outstanding interpersonal, communication, and organizational skills are essential.
* Energetic, interactive and comfortable working independently and also as part of a team
* Effectively communicates with investigators, coordinators, and co-workers
* Has strong computer skills as evidenced by proficient knowledge of Microsoft office tools (e.g., word, Excel, power point)
* Ability to collect and maintain data integrity
* Experience with EPIC and RedCap preferred
* Phlebotomy expertise preferred
* Penn CRC Certification required for internal applicants, or must be completed within first six months of hire for external applicants, and/or ACRP or SoCRA certification a plus.
Reference Number: 40-28058
Salary Grade: 027
Employment Type: Exempt
Job Family: I-Technical/Professional Research