REGULATORY AFFAIRS AND RECRUITMENT SPECIALIST
Posting DetailsPosting Details Reference Number 40-30586 Posted Job Title REGULATORY AFFAIRS AND RECRUITMENT SPECIALIST School Name Perelman School of Medicine Org DM-Renal-Electrolyte and Hypertension Posted to the Web 01/25/2019 Posted Job/Salary Grade 027 Employment Type Exempt Hours N/A Position Type Full Time Position Schedule 8-5p Months 12 Position Length Contingent Upon Funding Position End Date University Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.School/Center Overview
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/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.
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.
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.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. Quick Link http://jobs.hr.upenn.edu/postings/42988 Posting Supplemental Questions
Required fields are indicated with an asterisk (*).
- * How did you hear about this employment opportunity?
- [email protected]
- Contacted by a Penn Recruiter
- Referred by a Penn Employee
- Referred by a friend or family member
- Higher Education Recruitment Consortium (HERC)
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- * What is your highest level of education completed?
- Less than high school education
- High School Diploma or GED
- Vocational or Technical School
- Associate's Degree or Two Year College
- Bachelor's Degree
- Master's Degree
- PHD/MD/JD or equivalent doctoral degree
- * How many years of experience do you have related to this position?
- 0 to 1 Year
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