Position Status: Full-Time, Exempt
Reports to: Associate VP, Clinical Research
Location: Miami or New York or Telecommute
The Parkinson's Foundation (PF) makes life better for people with Parkinson’s disease (PD) by improving care and advancing research toward a cure. In everything we do, we build on the energy, experience and passion of our global Parkinson's community.
A prime focus of the Foundation is PD GENEration, a global, multi-center, genetic research study for people with PD.
The Manager of Clinical Research will be a key member on the Clinical Research team, focusing on study operations and recruitment strategy for diverse populations for PD GENEration. The role encompasses several aspects of clinical research including oversight of clinical research sites, Investigational Review Board (IRB) submissions, study start-up and maintenance, communication development internally and externally. The holder of this position ensures all studies are executed within predefined timelines and are conducted in compliance with GCP and all applicable standards and regulations. These responsibilities require the Manager of Clinical Research to possess exceptional judgment and a high level of knowledge of regulatory affairs in both US and ex-US markets.
Responsibilities include, but are not limited to the following:
- Direct site selection, enrollment, and recruitment processes.
- Assist in the development of tools for recruitment of diverse populations.
- Prepare all documentation for the Trial Master File, including case report forms, informed consent documents, investigator agreements, case report form completion guidelines, logic checks and data handling guidelines and other required documents.
- Plan, monitor and report patient accrual and implement corrective actions as necessary to meet accrual targets.
- Provide operational oversight of trials including report review, report preparation, review of monitoring plans, manual of procedures, data management plan, and other SOPs.
- Primary sponsor contact with investigational sites and vendors to resolve trial related problems.
- Prepare internal files and investigative sites for regulatory inspections.
- Complete closeout activities, including final reports.
- Maintain internal Quality System documents (SOP, etc.) in compliance with appropriate regulations.
- Travel to Foundation events with or on behalf of the Clinical Research team (10%).
- Participate in other projects and project teams as assigned.
- Job Complexity: Job requires maintenance of up-to-date knowledge of all applicable clinical guidelines and international clinical regulation and regulatory guidance.
- Supervisory Responsibilities: Supervises activities of external investigational sites.
- Bachelor’s degree in the life sciences or health care field.
- CCRC or SoCRA certification preferred but not required.
- Minimum 3 years in clinical research within biopharmaceutical or medical device industry or site-based experience as a study coordinator.
- Direct clinical research experience and supervision of clinical studies as clinical associate is required; demonstrated knowledge of GCP.
- In-depth knowledge of medical terminology and an understanding of the physiology and pathophysiology related to the relevant clinical trial.
- Excellent problem-solving skills with ability to resolve trial issues.
- Self-starter and excellent multi-tasking skills.
- Prior experience with EDC systems is required.
- Excellent computer skills, specifically with Microsoft Office Suite, is required.
- Professional presentation, verbal and written communication skills are required.
- Experience working with non-profit organizations on observational registry studies desired.
- Demonstrated ability to collaborate, multi-task and work effectively in a fast-paced environment.
- Demonstrates the organizational values of excellence, teamwork, collaboration, integrity, positivity, dedication, and responsiveness.
Compensation for this position is competitive and depends on prior experience. In addition, a comprehensive benefits package is included.
How to Apply
Please email resume and cover letter to Employment@Parkinson.org. Applicant review will continue until the position is filled. Please indicate the job title in the subject line. Resumes without cover letters will not be considered. No phone calls please.
The Parkinson’s Foundation is an equal opportunity employer. We are committed to diversity, equity, and inclusion in our culture and in our work on behalf of people with Parkinson's disease.
All new hires are required to be fully vaccinated against the COVID-19 virus, subject to any legally required accommodations.