Sr. Clinical Research Associate, Study Management, Medical AffairsLocation Apply
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Sr. CRA will perform clinical research duties within Medical Affairs (MAF) including but not limited to: protocol development, planning, implementation, conduct/oversight (i.e., meeting facilitation), site monitoring, site management, project tracking (timeline and budgets), vendor management and leading more junior Medical Affairs study staff. Candidates must have experience managing vendors, reviewing/approving monitoring visit reports, and exceptional skills writing study related documents (i.e. study manuals, protocols, training slides). Candidates can be based in San Rafael, CA or anywhere within the continential US.
- 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 BioMarin 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.
- 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.
- Experience writing study documents (i.e., protocol, ICD templates, eCRF Completion Guidelines, Monitoring Plans, etc.).
- Vendor Management experience
- Comprehensive powerpoint, excel and Word skills
- PleaseReview experience 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.
Bachelor’s degree, preferably in a scientific field
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.