Apr 08, 2019
Duties Timeline: Establishes and manages timelines for assigned study while considering strategic objectives and corporate priorities.
Monitoring: Ensures compliance of assigned sites with protocol, regulatory requirements and overall study objectives. Confirms the qualifications of investigators, and investigational sites throughout the conduct of a clinical study and assesses adherence to applicable regulatory requirements (e.g., ICH/GCP, CFR and country specific). Oversee CRO CRAs to ensure monitoring is completed according to study Monitoring Plan. Participates in co-monitoring visits for training opportunities with CRO CRAs.
Study Documents: Leads the preparation and finalization of study documents including, but not limited to: protocols, Informed Consent Form templates, periodic/interim/ annual/final reports and statistical analysis plans. Set-up, oversight and reconciliation of study documentation in official repositories (e.g., electronic systems).
Participates in or leads the planning and execution study meetings (i.e., study team meetings, investigator meetings, etc.).
Periodically reviews adverse events reported in the study and works with Pharmacovigiliance colleagues on reconciliation of safety databases. Oversees the medical monitor review of assigned medical review data listings to identify trends and discrepancies.
Identifies and manage data discrepancies for the entire study and coordinates the clinical monitoring activities to ensure that these discrepancies are resolved in the established timeframe for resolution.
Manages laboratory specimen collection and reconciliation process where applicable including interfacing with laboratory and vendors. Ensures supplies for specimen collection are adequate at the site and study/site staff are trained on collection and shipment processes.
Vendor Management: Participates in the selection & management (i.e., contracts, change orders, budgeting, tracking of planned vs actual spend) of study vendors as applicable.
Facilitate short and long term planning for assigned study.
Creates clinical study metrics and other study management reporting tools.
Identifies problems/issues and reports findings to Study Team. Develop and implement contingency plans for identified issues.
Skills: At least five years experience as a Clinical Research Associate. Experience in the management of multiple sites as a Clinical Research Associate is preferred.
Extensive experience with study design, planning and implementation.
Study documents writing experience (i.e., protocol, ICD templates, eCRF Completion Guidelines, Monitoring Plans, etc.).
Vendor Management experience
Experience with PleaseReview preferred.
Advanced verbal and written communication skills, in addition to excellent organizational skills and management of cross-functional teams.
Preferred: post-approval observational research experience.
Education: Bachelor’ s degree, preferably in a scientific field
Compass Consulting Group
San Rafael, CA, USA