CLINICAL RESEARCH COORD B/C

Duties: Clinical Research Coordinator B: With minimal supervision, coordinate Phase I - IV clinical trials and Investigator-Initiated Trials. Recruit, consent and screen patients according to protocol. Schedule patient visits and any necessary testing, Monitor patients per protocol requirements and ensure adherence to protocol requirements, Organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples, Participate in initiation, monitoring, audit and close-out visits, Participate in study team meetings, and ongoing protocol training/compliance meetings, Assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality. With minimal assistance, prepare and process of all Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments and adverse event reporting. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
Clinical Research Coordinator C: Independently manage Phase I-IV complex clinical trials, and Investigator-Initiated trials, including consenting and screening patients according to protocol. Schedule patient visits and any necessary testing, Monitor patients per protocol requirements and ensure adherence to protocol requirements, Organize and maintain all documentation required by the sponsor or CRO - includes source documentation, case report forms, and research charts. Collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples. Responsible lead for site initiation, monitoring, audit and close-out visits, communicating and addressing any noted concerns. Participate in study team meetings, and ongoing protocol training/compliance meetings. Responsible for the development/maintenance of study specific case report forms and source document tools. For any studies that involve multi-sites, the CRC C would liaison with other sites, ensuring compliance with study protocol and procedures. Be prepared to take the lead on IRB processes for both local and Central IRB's involving submissions, modifications, continuing reviews. Provide relevant input into study budget development. Show vigilance in patient safety, protocol compliance and data quality and ensure all time lines are met. Mentor other coordinators and serve as a role model. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Qualifications: Both levels of this position require effective problem solving abilities; outstanding interpersonal, communication, writing, organizational and time management skills are essential. Energetic, interactive and demonstrated ability to work as part of a team, as well as independently. Knowledge of IRB and Human Research Protection Regulations. The Clinical Research Coordinator 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; demonstrate interest in the work, a strong work ethic, and personal and professional integrity. Effectively communicates with investigators, coordinators, and co-workers; strong computer skills as evidenced by proficient knowledge of Microsoft office tools (e.g., Word, Excel, PpowerPoint). Ability to collect and maintain data integrity. Experience with EPIC/Penn Chart preferred. Phlebotomy expertise preferred.

Clinical Research Coordinator B:
* Bachelor's Degree and at least 2-4 years of experience in direct human subjects research or an equivalent combination of education and experience required
* Ability to coordinate Phase I-IV clinical trials with minimal supervision
* 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.

Clinical Research Coordinator C:
* Bachelor's Degree and at least 4-6 years of experience in direct human subjects research or an equivalent combination of education and experience required
* Ability to independently manage Phase I-IV complex clinical trials and ability to mentor coordinators
* 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: 40-26141

Salary Grade: 026/027

Employment Type: Exempt

Org: DE-Dermatology

Special Requirements:

Job Family: I-Technical/Professional Research