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Position Overview
This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Senior Clinical Research Associate I (CLRA) is responsible for site management deliverables on assigned protocols and may act as a lead CRA for the study, providing guidance and support to other CRAs on the team.
This position is field based / remote.
Essential Duties
Include, but are not limited to, the following:
- Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies.
- Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships.
- Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates.
- Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables.
- Support the Clinical Study Manager to develop study-specific training materials.
- Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams.
- Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.
- Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assists in co-monitoring or monitoring support of clinical sites/studies.
- Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team.
- Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate.
- Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management.
- Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and in-house and regional CRA team members.
- Assist with the creation of protocol, CRFs, and all other associated study documents.
- Support the Clinical Study Manager to develop, implement and execute, the clinical study Monitoring Plan. Ensure compliance with the plan and all assigned tasks throughout the study.
- Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members.
- Communicate project specific information to/from trial sites through teleconferences, newsletters, etc.
- Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis.
- Document monitoring activities in monitoring visit reports and follow-up letters.
- Communicate serious issues to appropriate parties, in a timely manner.
- Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed.
- Work with clinical study manager to manage vendors (i.e., Central Laboratory, CRF printers, CROs, etc.).
- Participate in Investigator Meetings, and other study trainings and meetings as required.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work designated schedule.
- Ability to work nights and/or weekends, as needed.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to work on a computer and phone simultaneously.
- Ability to use a telephone through a headset.
- Ability and means to travel 10% between Exact Sciences locations.
- Ability to travel 50% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- Bachelor’s Degree in field as outlined in essential duties or
- Associate degree with a minimum of 6 years of monitoring experience or equivalent experience.
- Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience.
- 4+ years clinical research monitoring experience or equivalent experience.
- No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability.
- Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems.
- Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively.
- Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices.
- Meticulousness with a focus on accuracy and precision in all tasks and activities.
- Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Preferred Qualifications
- Experience or knowledge in In Vitro Diagnostics (IVD).
- Certifications related to clinical research.
- Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
- Strong on-site monitoring experience in clinical trials, including:
- Site initiation.
- Routine monitoring visits.
- Site closeout.
- Knowledge of electronic trial master file (eTMF) systems and document management processes.
- Experience in training and mentoring junior CRAs or clinical research staff.
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Salary Range:
$91,000.00 - $155,000.00 (National Salary)
$98,400.00 - $147,600.00 (California Salary)
The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible.
Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.
To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.
Originally posted on Himalayas