Associate Director, Clinical Research

Position: Associate Director, Clinical Research

Position Status: Full-Time, Exempt

Reports to: Senior Director, Clinical Research

Location: Remote

DESCRIPTION:

The Parkinson's Foundation (PF) makes life better for people with Parkinson’s disease 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: Mapping the Future of Parkinson’s Disease. PD GENEration is a national initiative that offers genetic testing for clinically relevant Parkinson's-related genes and genetic counseling at no cost for people with Parkinson’s disease.

The Associate Director of Clinical Research will be a key member on the Clinical Research team, focusing on PD GENEration. This role will hold the primary responsibility of supporting the execution of the PD GENEration study and the planning potential sub-studies led by the Parkinson’s Foundation in collaboration with other members of the PD GENEration team. This encompasses all aspects impacting the completion of a trial, including development of study project plans, study start-up, monitoring of trials in progress, vendor management, reporting and publication of study results. The holder of this position ensures all studies are executed within predefined timelines and budgets and are conducted in compliance with GCP and all applicable standards and regulations. These responsibilities require the Associate Director of Clinical Research to possess exceptional judgment and a high level of knowledge of clinical research.

RESPONSIBILITIES:

Responsibilities include, but are not limited to the following:

• Develop clinical protocols, providing strategic and tactical input for design and execution alongside clinicians and people with Parkinson’s disease.
• Prepare and present study project plan including timelines and budgets for final approval.
• Vet new study vendors and execute new collaborations with vendors.
• Manage trial vendors including CRO, Data Management, and external collaborators.
• Direct site selection, enrollment and recruitment processes.
• Oversee investigator budget and contract execution in collaboration with internal teams (Grantmaking Operations team) and at investigational sites.
• Develop and implement strategic recruitment contracts and events with sites focusing on diverse recruitment.
• Prepare all documentation for the Trial Master File required for clinical trials, 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.
• Primary contact for cross-functional study team including Clinical Affairs, Community Engagement, Community Education, Development, Corporate Partnerships, Communications, Accounting and Finance.
• Provide accurate and timely study updates for internal and external stakeholders.
• Manage all vendor resources and activities to ensure study is being conducted according to protocol, timelines and budget.
• Manage all internal resources allocated to the trial and oversee internal activities to plan and execute the clinical trial.
• 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.
• 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 Contract Research Organizations and investigational sites.

EXPERIENCE/SKILLS REQUIRED:

• Bachelor’s degree in the life sciences or health care field.
• CCRC or SoCRA certification preferred but not required.
• Minimum 5 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 project leader or 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.
• Excellent project management skills and planning competencies to set plans and execute on time and within budget.
• Experience managing CROs and outside vendors to plan and execute Phase I- IV and/or observational clinical trials.
• 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:

Salary for this position is competitive and depends on prior experience and location. In addition, a comprehensive benefits package is included. In addition, a comprehensive benefits package is included. The salary range for this position is $75,000 to $85,000

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.