Multisite Clinical Research Project Manager

Opportunity for Health; Philadelphia (Philadelphia County); On-site; USD 63,000 - 75,000; Full time

Job summary

The University of Pennsylvania is seeking a Clinical Research Project Manager A to oversee day-to-day operations of clinical research projects under guidance from senior staff at the Perelman School of Medicine in Philadelphia.

You will assist with protocol development, coordinate at single or multicenter sites, develop regulatory submissions, and support grant applications. Supervision of staff and study visits may be included as needed.

Qualifications

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

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.
• 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 device 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.

Skills

REDCap

Recruiting experience

Education

Bachelor's Degree

Job description

The University of Pennsylvania is seeking a Clinical Research Project Manager A to oversee day-to-day operations of clinical research projects under guidance from senior staff at the Perelman School of Medicine in Philadelphia.

You will assist with protocol development, coordinate at single or multicenter sites, develop regulatory submissions, and support grant applications. Supervision of staff and study visits may be included as needed.