Senior Clinical Research Associate
Premier Research is looking for a Senior Clinical Research Associate to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
What You’ll Be Doing:
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines;
- Maintains submission of expenses according to travel and expense requirements within company guidelines;
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements;
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations;
- Plans day to day activities for monitoring of a clinical study and sets priorities per site;
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan;
- Monitors with knowledge of quality/scope/timeline and budget parameters;
- Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase;
- Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member;
- Manages query resolution process with sites and Premier Research Data Management;
- Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates;
- Assists project team with assessing project feasibility and recruitment, as applicable;
- Maintains project tracking system of subjects and site information, as applicable;
- Participates in Investigators’ Meeting as designated by the Project Manager;
- Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts;
- Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager;
- Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan;
- In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description;
- In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead.
What We Are Searching For:
- Bachelor’s degree, or local equivalent, in a clinical, biological, scientific, or health-related field or its international equivalent;
- 4+ years of independent on-site monitoring experience with all types of site visits;
- Completion of a CRA training program through a CRO.
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