Clinical Research Project Manager - Flexible Hours

University of Pennsylvania Perelman School of Medicine; Philadelphia (Philadelphia County); On-site; USD 63,000 - 71,000; Full time

Job summary

University of Pennsylvania Perelman School of Medicine in Philadelphia, PA, is seeking a Research Project Manager A to oversee end-to-end management of clinical and translational studies within the Laboratory for the Investigation of Autoimmunity Pathogenesis. The role requires coordinating with internal departments, Penn entities, and external sponsors to ensure study integrity.

The position involves subject recruitment, regulatory documentation, data management, and quality control, with

Qualifications

• Bachelor’s Degree with 3-5 years of related experience or equivalent combination of education and experience is required.
• Strong planning and organizational capabilities along with exquisite attention to detail, excellent follow through and problem-solving skills necessary.
• Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously.

Responsibilities

• Manage day-to-day operations of multiple research projects.
• Recruit, screen, and enroll potential study subjects as specified per protocol.
• Conduct study visits and collect specimens.
• Monitor and track subjects.
• Collect, review, and report timely, valid, accurate study data for studies with patients in long-term survival follow up.
• Oversee cataloguing and distribution of biological samples.
• Develop and implement study protocol designs, construction of source documents, databases, and case report forms.
• Maintain databases and study documentation.
• Prepare and submit Institutional Review Board (IRB) documentation including submissions, continuing reviews and amendments.
• Prepare and submit documentation to other regulatory bodies such as the Abramson Cancer Center.
• Coordinate and facilitate study related meetings and communications.
• Create data reports and meeting presentation materials to present at weekly or recurring meetings with team leadership and team members.
• Review the status of studies including accrual, data entry, queries, deviations, and identification and resolution of subject issues.
• Assist with data cleaning and quality control for large volume interim analysis.
• Show vigilance in patient safety, protocol compliance and data quality.
• Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Skills

Project management

Attention to detail

Problem solving

Communication

Education

Bachelor's degree

Job description

University of Pennsylvania Perelman School of Medicine in Philadelphia, PA, is seeking a Research Project Manager A to oversee end-to-end management of clinical and translational studies within the Laboratory for the Investigation of Autoimmunity Pathogenesis. The role requires coordinating with internal departments, Penn entities, and external sponsors to ensure study integrity.

The position involves subject recruitment, regulatory documentation, data management, and quality control, with