"Clinical Research Quality Specialist B (Department of Office of Clinical Research)"

Job Description

Posted Job Title
Clinical Research Quality Specialist B (Department of Office of Clinical Research)

Job Profile Title
Clinical Research Quality Specialist B

Job Description Summary
The Clinical Research Quality Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Associate Director, PSOM Office of Clinical Research Compliance. The Clinical Quality Specialist will work as part of the Compliance team to help support and facilitate clinical research at the University of Pennsylvania. The Clinical Research Quality Specialist will work with senior team members to facilitate and conduct high quality compliance reviews, which include review preparation, conduct, close out and reporting, to ensure compliance with federal regulations and institutional policies. This position will interface with research investigators and staff throughout the review process. Within the OCR, the Clinical Research Quality Specialist will interface with other OCR Units to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives and to participate in research staff training.

Job Description:
The Clinical Research Quality Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Associate Director, PSOM Office of Clinical Research Compliance. The Clinical Quality Specialist will work as part of the Compliance team to help support and facilitate clinical research at the University of Pennsylvania. The Clinical Research Quality Specialist will work with senior team members to facilitate and conduct high quality compliance reviews, which include review preparation, conduct, close out and reporting, to ensure compliance with federal regulations and institutional policies. This position will interface with research investigators and staff throughout the review process. Within the OCR, the Clinical Research Quality Specialist will interface with other OCR Units to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives and to participate in research staff training.

Job Responsibilities:

• Assist in the facilitation and conduct of compliance reviews for assigned Sponsor and Investigators, including preparation, reporting and close out.
• Provide support to Investigators and research staff in the development of research protocols, informed consent forms, case report forms, and other related study documentation.
• Conduct training of Investigators, Sponsors and Clinical Research Staff in areas related to clinical research
• Support other OCR divisions as needed: IND/IDE Unit, Operations, Billing, Clinical Contracting
• Assist in other system-wide compliance related oversight initiatives (i.e., PICA tracking, training tracking, Ct.gov tracking and maintenance)
• Perform additional duties as assigned

Qualifications

• Bachelor's degree and 3-5 years of experience. Experience in clinical/translational research compliance and/or operations in any of the following areas: academia, pharmaceutical, contract research organization (academic or private sector), or site management organization (academic or private).
• Experience in the following areas preferred:
  • Compliance oversight for clinical trials; monitoring or auditing of studies
  • Development of protocols, consent forms, and case report forms
  • Coordination of clinical research studies
  • Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines
• Ability to respect and protect highly sensitive and confidential information

Cover letter and resume required with application

Targeted Pay Range: $69,953-77,123
This Targeted Pay Range is only applicable to this job posting. All salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

Job Location - City, State
Philadelphia, Pennsylvania
Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.

Department / School
Perelman School of Medicine

Pay Range
$62,000.00 - $77,123.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/HUP/Clinical-Research-Quality-Specialist-B--Department-of-Office-of-Clinical-Research-_JR00099973-1