Clinical Research Project Manager

Description :

The Clinical Research Project Manager trains research staff, supervises staff and oversees clinical trials from start-up to close-out.

Develops and / or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents team internally and externally, and oversees research operation in department, and provides expert consulting at an institutional level.

ESSENTIAL FUNCTIONS :

Manages all Investigator-lead multi-site trials by developing and implementing processes for document management and IRB submission tracking (.

continuing reviews and amendments) for multi-center trials as well as have protocol status knowledge.

• Directs the preparation and submission of regulatory agency applications, reports, and correspondence for opening new studies, protocol amendments, informed consents, continuing reviews, FDA safety reporting, Investigational New Drug applications (INDs), annual reports, Investigational Device Exemption applications (IDEs), etc.
• Provides direct supervision of the research staff which includes conducting on-going training, reviewing workloads, completing annual evaluations, etc.
• Oversees documentation efforts to ensure compliance with domestic and international regulations and standards.
• Identifies issues, recommends changes, writes new standard operating procedures (SOPs) or update existing SOPs with the goal of enhancing regulatory compliance.
• Interacts with co-workers, visitors, and other staff consistent with the company values.
• Oversees the completion of all necessary regulatory preparations prior to sponsor visits (., monitoring and auditing visits, site activation visits).

Ensures that any regulatory action items resulting from a sponsor visit are completed in a timely and efficient manner.

• Ensures that regulatory document version control is maintained, and that all clinical trial documentation is audit ready" at all times.
• Reviews all regulatory submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Creates and establishes a process for ensuring quality submissions to the IRB and the FDA.
• Works with the Team to ensure all communications regarding regulatory documentation that are provided by sponsors are distributed and received by the regulatory staff in a timely manner.
• Actively participates and represents the departments in feasibility assessments.
• Manages all aspects of clinical research regulation from protocol inception to completion; and tracking quality metrics
• Directs regulatory documentation and workflow for clinical trials through the use of project management techniques and tools (.

spreadsheets, progress reports, priority setting).

• Maintains an efficient organizational structure for processing all clinical protocols assigned to the Team, which includes NCI cooperative group protocols, industry-sponsored trials, and investigator-initiated studies including multi-sites.
• Performs other duties as assigned.

Additional Skills & Qualifications :

• Bachelors of Science
• 5+ years of clinical research experience
• Experience overseeing teams
• Oncology experience required
14 days ago