Sr. Clinical Research Associate - Women's Health
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Sr. Clinical Research Associate to bring their passion to our Women's Health team.
As a Senior CRA, you will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
- Deliver quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
- Maintain submission of expenses according to travel and expense requirements within company guidelines
- Be 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
- Monitor (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Plan day to day activities for monitoring of a clinical study and sets priorities per site
- Prepare for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan.
- Take the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
- Monitor with knowledge of quality/scope/timeline and budget parameters
- Work with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
- Monitor 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.
- Manage query resolution process with sites and Premier Research Data Management
- Maintain 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.
- Assist project team with assessing project feasibility and recruitment, as applicable
- Maintain project tracking system of subjects and site information, as applicable
- Participate 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.
- Attend meetings as required
- Ensure site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
- Complete timely entry of hours worked and project codes per time entry guidelines
- Maintain high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients
- Acquire basic knowledge of disease or condition under study.
- Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
- Maintain proper, timely communication with study teams and management, as needed.
- Complete all required internal training (general and study-specific) on-time.
- Identify confidential information and complies with global and local laws and guidelines
- 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
- Other activities as designated
- Act as a resource/mentor for other CRAs and shares knowledge base and best practices.
- Undergraduate degree or its international equivalent in clinical, science, or health- related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Previous clinical research experience required, completion of CRA training program
- Experience in coaching/mentoring other CRAs
- Global experience preferred
- At least 4 years’ experience in clinical trials
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job. Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site monitoring activities will be carried out