Senior Clinical Research Associate II - United States
- 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 our 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 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
- 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
Equal opportunity :