Research Project Manager A

About the role

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.

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.
• Maintain databases and study documentation.
• Prepare and submit Institutional Review Board (IRB) documentation including submissions, continuing reviews and amendments.
• 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.
• Adequately manage 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.

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.
• 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.

Skills

• Strong organizational and communication skills.
• Ability to manage multiple projects simultaneously.
• Experience with regulatory processes and compliance.
• Proficiency in Microsoft Office Suite.
• Ability to work independently and as part of a team.

Benefits

The University of Pennsylvania 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.