Clinical Research Manager A

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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.

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.

Posted Job Title

Clinical Research Manager A

Job Profile Title

Clinical Research Project Manager A

Job Description Summary

Manages day-to-day operations of clinical research projects under guidance from senior staff. Assists with protocol development, project coordination at single or multicenter sites, and quality control of data. Supports grant applications, prepares reports and presentations, and contributes to dissemination of study findings. May supervise project staff and participate in study visits.
Job is contingent upon funding.

Job Description

Job Responsibilities

• With supervision, manage single and/or multi-site clinical research projects including study start up, daily operations, external site communications, recruitment and enrollment, and troubleshooting;  quality assurance and quality control;  study close out activities. May include study visits and procedures, when needed, to meet the needs of the project.

• Develop, create and review regulatory submission and study documents/tools, including protocols, consents, annual reports, source documents, training slides, manual of procedures, Data Safety Monitoring Board charter, case report forms and standard operating procedures.  Provide assistance with investigational new drug, investigational devise and clinical trial agreement exemption determinations.

• Assist/conduct pre-award finance activities including medical record abstraction, medicare coverage analysis development, clinical trials management system registration, research billing number, driving contract timelines, budgeting input or development, grant writing assistance); and/or post award finance activities (invoicing, billing review)

• Staff supervision:  Assist and train direct and/or indirect clinical research staff in program, division or dept procedures as required per protocol(s); includes onboarding, data and lab management, protocol compliance, quality control, quality assurance, human subjects protection, good clinical practice, project assignments, staff mentoring and bi-annual performance appraisal completion.

• Perform additional duties as assigned.

• Job is contingent upon funding.

Qualifications

• Bachelor's Degree with 3-5 years of related experience or equivalent combination of education and experience is required.

Job Location - City, State

Philadelphia, Pennsylvania

Department