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Senior Clinical Research Associate San Rafael United States,
Posted on : 02 June 2017
- Our company 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.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company 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 Senior Clinical Research Associate (SR. CRA) role is a critical role at our company, holding key responsibilities for the execution of the clinical trial and driving day-to-day activities in support of clinical trial milestones.
- A Sr. CRA takes on a primary role as a Regional Study Lead for company's Clinical Operations.
- The Regional Study Lead leads all day-to-day Clinical Operations (CLO) functional activities associated with the execution of the global clinical trial in an assigned region (e.g. US, EU, Asia). As a Regional Study Lead, the Sr. CRA is responsible for oversight of the regional study team, the regional Clinical Research Organizations (CROs), and regional third party vendors associated with the study.
- It is expected that the Regional Study Lead is capable of overseeing and executing on all delegated tasks associated with clinical trial execution.
- A Sr. CRA may also perform the CRA role on highly complex studies.
- Following demonstrated success in the Regional Study Lead role, the Sr. CRA may have the opportunity to take on the Study Lead role.
Study Planning & Management
Responsible for regional study planning activities as agreed and delegated by the Study Lead, such as:
- Participate with Study Lead on regional study feasibility assessment activities (if applicable)
- Ensure timely development and finalization of region specific sections of study plans and manuals as per the study team / project team charter.
- Contribute to the development and review of region specific elements of critical study documents, such as study protocol, eCRF, ICF template, and others
- Identify regional CLO risks and mitigations and share with the Study Lead
- Identify, resolve or, if necessary, escalate regional CLO issues that have a significant impact to overall global CLO study timelines, other functions, budget or quality to the Study Lead as per study team / project team charter
- Lead CLO regional study activity timeline development and contribute to regional study budget development and management
- Provide regional/local operational and regulation knowledge to Study Lead as related to the study(ies) in support of enrollment strategies
- Provide regional study status updates to Study Lead
- Contribute to regional vendor evaluation and selection process
- Oversee day-to-day regional CRO and vendors contracted activities as per regional oversight plans
- Work with COA to ensure final payments to regional vendors at study closure
Responsible for all region-specific study conduct activities, including:
- Lead site identification, qualification, selection and activation activities for the study, such as site and staff training, site budgets, site or country specific ICF and site investigator contracts
- Plan and deliver IM in collaboration with other key stakeholders
Enrollment and Maintenance:
- Ensure adherence to study enrollment strategy and plan
- Ensure adherence to monitoring plan
- Ensure adherence to monitoring oversight SOP
- Ensure timely site payments
- Partner with Patient Advocacy to manage patient travel, housing and associated patient management costs as applicable for the study
- Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
- Coordinate and oversee data listing reviews
- Ensure timely uploading of clinical documents for the CSR appendices
- Support Study Lead on any delegated cross-functional activities
- Train and mentor junior regional team members such as CRAs and CTAs
- Prepare regional standard metrics (KPIs, SQMs) for global study dashboards to routinely monitor team activities and ensure compliance to timelines, quality and budget
- Provide forecast for regional clinical supply, including ancillary supplies and comparator drugs
- Ensure compliance with regional regulations, GCP, and SOPs during the execution of the study
- Contribute expertise to departmental and cross-functional process improvement activities
EDUCATION / EXPERIENCE:
- BA/BS or higher in nursing, life or health sciences is preferred.
- 7-10 years of relevant pharmaceutical /biotech industry experience
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.
San Rafael California
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