Duties: Under minimal supervision, responsible for independently coordinating all phases of studies for sponsored research within the Renal-Electrolyte and Hypertension Division, including regulatory and IRB submissions. Identify and recruit subjects to participate in research studies. Involves reviewing patient records, screenings, speaking with patients and maintaining databases of potential participants. Consent, screen, enroll potential study participants and perform study visits per protocol. Schedule patient visits and any necessary testing. Process and ship blood, urine and other specimens for trials. Adhere to all University of Pennsylvania, human research protection, and FDA guidelines. Prepare and process all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting and all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Create and maintain master trial file and obtain the appropriate signatures for regulatory forms.
Responsible for conducting study initiation. Responsible for the creation and maintenance of master trial files for +/- 25 clinical studies. Coordinate, organize and maintain all documentation required by sponsor or CRO as it relates to study start-up (source documentation procurement/creation, case report forms, study and regulatory binders, and patient binders). Create and maintain master trial file and obtain the appropriate signatures for regulatory forms. Submits regulatory submissions to the IRB and other research review boards at Penn. Submit renewals and amendment submissions, consent form revisions, continuing reviews, and adverse event. monitoring all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Compliance Oversight for clinical trials; monitoring or auditing of studies with CROs, the FDA and other entities as required for the Division. Work with research teams to prepare for audits including reviewing regulatory binders and performing internal audit and other internal QA activities. Resolve regulatory- related queries with the IRB, study sponsors, and CROs. Develop and maintain standard operating procedures. Maintain a current knowledge of relevant regulations and oversee, revise, and update documentation in order to ensure compliance. Also when indicated, facilitate and perform Central IRB submissions and reviews. Participate in audits by study sponsors, CROs, the FDA and other entities as required for the Division. Represent the division to external organizations (sponsors and CROs) during site selection process, Site Initiation Visits, and study close-out process. Conduct initiation, monitoring and closeout visits with sponsors and/or CROs. Attend Investigator Meetings as the representative for the Division building collaborations with other academic researchers, institutions, and other sponsors. Act as a back up CRC as needed. Perform patient recruitment for sponsored research in the Renal Division. Recruit, screen and enroll potential study patients as specified per protocol. Schedule patient visits and perform any necessary testing. Obtain records required to complete/assess study eligibility
Position is contingent on continued funding.
Qualifications: A Bachelor's Degree and 4 years to 6 years of experience or an equivalent combination of education and experience required.
Knowledge of IRB and Human Research Protection Regulations . Good Clinical Practices (GCP) required, as well as the relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR) and International Conference of Harmonization (ICH) Guidelines. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate excellent written and verbal communication skills; a clear attitude of customer service; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities, and the ability to build and maintain positive working relationships at all levels of the institution.
Reference Number: 40-30586
Salary Grade: 027
Employment Type: Exempt
Org: DM-Renal-Electrolyte and Hypertension
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research