Senior Clinical Research Associate - United States
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- 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 Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. 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 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.
- 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 mitigation 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
- 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
- Direct Industry / Sponsor experience heavily preferred especially in biologics