Clinical Research Associate II - United States
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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 Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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 CRA II position holds essential responsibilities for successful clinical trial execution at BioMarin.
A CRA II takes on the key CRA role on BioMarin studies contributing to or leading critical tasks related to site monitoring, site management and/or study management and oversight activities as delegated by the BioMarin Study Lead or Regional Study Lead.
Study Planning & Management:
Contribute to or lead key study planning and management tasks as delegated by Regional Study Lead or Study Lead, such as:
• Conduct study feasibility assessment activities (if applicable)
• Develop key study plans and manuals as per the study team / project team charter
• Develop of critical study documents, such as study protocol, eCRF, ICF template, and others
• Identify CLO risks and mitigations and aligning with cross-functional Study Team on overall Risk
• Identify, resolve or, if necessary, escalate functional area issues that have a significant impact on overall study timelines, other functions, budget or quality to Study Team as per study team / project team charter
• Develop study timelines
• Define enrollment strategies and plan for the study
• Provide study status updates
• Prepare Investigator Meeting materials
• Design and prepare study related materials for the training of internal and external staff
Contribute to or lead key vendor management tasks as delegated by Management Regional Study Lead or Study Lead, such as:
• Contribute to vendor evaluation and selection process
• Conduct day-to-day management of CRO and vendors’ contracted activities as per oversight plans
• Ensure final payments to vendors at study closure
Study Conduct :
Contribute to or lead key study conduct and monitoring tasks as delegated by Regional Study Lead or Study Lead, such as:
• Conduct site activation activities including site training, site budget preparation, site ICF reviews, SIV visits, and facilitation of investigator contracts
Enrollment and Maintenance:
• Execute on study enrollment strategies
• Conduct site monitoring visits and monitoring oversight as per the monitoring and oversight plans, which entails review and finalization of site visit reports and tracking and follow-up of any significant site management issues
• Prepare timely site payments
• Maintain study status updates and tracking of all study execution milestones
• Conduct study closure activities (sites, reconciliation activities, filing & archiving)
• Conduct data listing reviews
• Ensure timely delivery of clinical documents for the CSR and appendices
Cross- Functional Representation:
- May collaborate with other functions as needed to support execution of CLO cross-functional activities, such as: user requirement specification review (IXRS, Global Labs, Specialties Labs), user acceptance testing, and data review
Additional responsibilities may include:
• Coach and mentor CTAs
• Determine clinical supply requirements, including ancillary supplies and comparator drugs
• Ensure compliance with ICH, GCP, SOPs during the execution of the study
• Contribute expertise to functional and cross-functional process improvement activities, as needed
• Execute on TMF maintenance
- 3-4 years of pharmaceutical industry or relevant experience
- 2 years of experience in a CRA functionalrole
- BA/BS or higher in nursing, lifeor health sciences is preferred.
- Industry or relevant experience inlieuof education is considered.
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.