Research Project Manager A

Job Description Summary

The Research Project Manager A, with limited oversight, provides end-to-end management across the full study lifecycle of clinical and translational research studies conducted in and by the Laboratory for the Investigation of Autoimmunity Pathogenesis led by Sokratis Apostolides, MD. These studies require collaboration with multiple internal departments and institutes, other Penn entities, and external sponsors. This position will oversee the detailed operations of clinical research activities including subject recruitment, conducting research visits, data entry, analysis and quality control, maintenance of regulatory documentation.

Job 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.

Position Contingent Upon Funding

Qualifications

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

Preferred: 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. Successful candidates will have the ability to anticipate problems relating to projects and to develop and implement solutions. Flexibility and the drive to meet project deadlines required. Proficient in Microsoft Windows, reference management software, and databases such as REDCAP. Knowledge of regulatory processes required. Excellent written and verbal skills required.