PositionOverview

• Manages company-sponsored and investigator-sponsored clinical studies in line with institutional, GCP, regulatory, and compliance requirements
• Collaborates with study PIs, coordinating centers, CROs, and/or sponsoring institutions to develop protocols, establish budgets, construct databases, select sites, set enrollment targets, and implement enrollment and mitigation plans
• Works with legal team to facilitate preparation of clinical trial agreements, physician consulting agreements, and other related contracts
• Partners with study site coordinators to prepare IRB submissions and address IRB questions
• Prepares/assists in the preparation of study documentation including protocol amendments, Case Report Forms, Informed Consent Forms, and monitoring plans
• Facilitates/supports training of and communication with study sites/subsites via regular email/phone contact, study newsletters, and in-person investigator and coordinator meetings
• Reports, tracks, and interprets study data, enrollment trends, and other metrics
• Ensures appropriate safety/adverse events reporting
• Tracks and manages study budgets and expenditures
• Provides regular study status reports to management and internal business partners
• Reviews publication drafts and fields physician requests for publication support as needed
• Leads pilot data collection efforts as needed
• Attends study investigator/coordinator meetings, offsite study meetings, and other professional conferences as needed to support study startup and enrollment
• Directs Clinical Research Associates, Clinical Research Coordinators, and administrative personnel as needed to support the above activities
• Performs other clinical research-related duties as assigned

Desired Qualifications:

····IDEand/or global clinical research experience a plus