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University of Pennsylvania · 1 day ago

Clinical Research Project Manager A

HUP

Full-time

Onsite

Mid Level

$62K/yr - $74K/yr

3+ years exp

The University of Pennsylvania is a world-renowned leader in education, research, and innovation. They are seeking a Clinical Research Project Manager A to manage and oversee the FTDC's industry funded clinical trials portfolio, focusing on interventional studies in young onset neurodegenerative diseases.

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Growth Opportunities

Responsibilities

Oversee all clinical visit activities including recruitment, enrollment, collection and processing of study data and biological samples, data entry and queries, and completion of monitoring and closeout visits

Supervising up to six clinical research coordinators

Supportive oversight of study teams, study conduct and study closeout

Active management of ongoing longitudinal projects

Ensuring protocol compliance in accordance with established timelines, institutional policies, sponsor requirements, CRO requirements, federal regulations and good clinical practices

Prioritizing efforts of the study team

Overseeing timely and accurate data collection, research billing

Assisting the Clinical Research Program Lead with developing and updating center processes and standard operating procedures

Assisting with staff on-boarding and ongoing training activities

Assisting in interviewing CRC hiring candidates

Management of essential and source documentation

Management of recruitment, enrollment, and retention of subjects

Management of invoicing per protocols as relevant

Oversee human subject protection policies and procedures

Troubleshooting operational issues

Assisting with all aspects of research coordinators’ work during absences or when a coordinator’s workload exceeds capacity

Communication with patients and staff outside of office hours

Flexible hours to adapt to protocol requirements, which may include evenings or weekends as necessary

Qualification

Clinical trial managementNeurodegenerative disease experienceRegulatory compliance knowledgeData managementProject oversightMulti-tasking capabilitiesCommunication skillsOrganizational skillsProblem-solving abilities

Required

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

Prior experience with early onset neurodegenerative disease, industry-sponsored trials, early phase trials, ethics committees and/or clinical research

Excellent planning, organizational and multi-tasking capabilities

Effective prioritizing and problem-solving abilities

Strong communication and writing skills

Preferred

Prior experience with relevant regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines, funding policies, NIH, and other grant procedures