As a Clinical Research Study Coordinator within CVS Clinical Trial Services (CTS) you are a vital part of our team’s success. In your role you manage study sites at the regional level including daily operations, healthcare provider support, building and maintaining stakeholder relationships, and maintenance of study documents and internal documents.
What you’ll do:
• Manage clinical trial operations regionally including communications with the academic medical centers, Institutional review boards, vendors, and Sponsors.
• Support healthcare providers, ensuring study protocol adherence, study related activities align with company policies and operate within ICH and GCP guidelines.
• Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
• Develops accurate source materials, including study specific checklists and ensures compliance from site staff.
• Create and maintain study documents requested by sponsor, CRO, study manager or CVS Health Leaders.
• Train trial delivery staff on protocol specific requirements, terminology, and procedures.
• Manage and prepare study materials/equipment, documentation, storage, and disposal/return.
• Ensure essential documents (IB, protocol, ICFs and CRFs) are current and maintained.
• Coordinate internal and external study events/meetings including SQV, SIV, IMV and trainings, audits and inspections.
• Draft and submit IRB submissions which include initial submission, annual review, study closeout SAE reporting and protocol deviations.
The typical pay range for this role is:
Please keep in mind that this range represents the pay range for all positions in the job grade within which this position falls. The actual salary offer will take into account a wide range of factors, including location.
• 3+ years of experience coordinating multi center or multiple clinical trials and managing regulatory or relevant work/educational experience
• 3 years of experience with Good Clinical Practice (GCP) and ICH guidelines
• Ability to work both virtually and on-site
• Ability to travel up to 50% of the time
COVID-19 Vaccination Requirement
CVS Health requires certain colleagues to be fully vaccinated against COVID-19 (including any booster shots if required), where allowable under the law, unless they are approved for a reasonable accommodation based on disability, medical condition, religious belief, or other legally recognized reasons that prevents them from being vaccinated.
You are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status or apply for a reasonable accommodation within the first 10 days of your employment. Please note that in some states and roles, you may be required to provide proof of full vaccination or an approved reasonable accommodation before you can begin to actively work.
• Comprehensive knowledge of GCP and ICH guidelines
• ACRP or SOCRA Certification
• Experience with preparing for and successfully managing regulatory and sponsor inspections.
• Experience conducting clinical research in multiple therapeutic areas.
• Experience coordinating study activities for multi-center studies
• Experience with Epic
High school diploma or GED equivalent
Bring your heart to CVS Health
Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we deliver our services is just as important as what we deliver.
Our Heart At Work Behaviors™ support this purpose. We want everyone who works at CVS Health to feel empowered by the role they play in transforming our culture and accelerating our ability to innovate and deliver solutions to make health care more personal, convenient and affordable.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day.
CVS Health is an affirmative action employer, and is an equal opportunity employer, as are the physician-owned businesses for which CVS Health provides management services. We do not discriminate in recruiting, hiring, promotion, or any other personnel action based on race, ethnicity, color, national origin, sex/gender, sexual orientation, gender identity or expression, religion, age, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.