Clinical Research Associate

This is a fully remote position, open to applicants in Ohio.

📋 Description

• Act as the main contact at the site level for both internal and external stakeholders involved in clinical trials.

• Execute site qualification, initiation, routine monitoring, and closure visits throughout all phases of trials.

• Ensure compliance with protocols, BMS standard operating procedures (SOPs), ICH Good Clinical Practice (GCP), and relevant regulations.

• Validate clinical trial data in both electronic systems and paper documentation for accessibility, completeness, and accuracy.

• Oversee site compliance, provide training, support, and engage in audits and inspections.

• Foster relationships with cross-functional teams, vendors, clinical sites, and key stakeholders.

• Inspire and influence sites to achieve enrollment and retention goals.

• Produce timely, accurate, concise, and professional monitoring and administrative reports.

• Evaluate Investigators and sites for resources and capabilities, identifying potential new sites.

• Implement targeted, centralized, remote, and risk-based monitoring strategies.

• Recognize and prioritize site and study risks, aiding in the development of mitigation strategies.

• Analyze site data and operational metrics, adjusting monitoring strategies based on observed trends and performance.

• Carry out Unblinded Site Monitor tasks when necessary to maintain study blinding.

• Review, reconcile, and oversee study drug/investigational medicinal product (IMP) and assist with label translation needs when required.

• Aid in regulatory compliance audits, inspections, and corrective and preventative measures.

• Support study start-up processes, submissions, informed consent form (ICF) reviews, and site document collection as needed.

• Assist in gaining access to BMS and vendor systems while maintaining internal systems for monitoring operations.

• Coordinate site activities related to database locks.

• Conduct timely site closure activities after completion of necessary visits and follow-ups.

⛳️ Requirements

• Bachelor’s degree is required, preferably in life sciences or a comparable field.

• 2–3 years of pertinent clinical research experience.

• A valid driver’s license is required based on local regulations.

• Capability to work independently and demonstrate proficiency in all facets of the role.

• Experience in the drug discovery and development process.

• Understanding of clinical research processes, regulations, and methodologies.

• Practical knowledge of medical environments and medical records management.

• Familiarity with ICH/GCP Guidelines and applicable local statutes and regulations.

• Strong analytical and critical-thinking capabilities.

• Ability to evaluate complex data sets and identify issues, trends, and outliers.

• Adaptability, a growth mindset, and the ability to learn and implement new technologies.

• Strong organizational and time-management skills.

• Ability to cultivate and sustain relationships with both internal and external stakeholders.

• Proficient verbal and written communication skills in English and the local language.

• Foundational understanding and awareness of relevant diseases.

• Ability to operate independently with a high level of autonomy.

• Capacity to manage multiple protocols across various therapeutic areas.

• Proficiency in clinical systems such as CTMS, eTMF, and RBQM dashboards.

• Proficiency in Microsoft Office Suite.

• Proficiency in Electronic Data Capture Systems (eDC).

• Experience with Risk-Based Monitoring tools and platforms like Veeva, Medidata, or CluePoints.

• Willingness to travel up to 70% of the time.

• Experience or foundational knowledge in artificial intelligence is strongly preferred.

• Previous employment with a Pharma/Biotech Sponsor or as a clinical study coordinator is preferred.

🏝️ Benefits

• Additional discretionary incentive cash and stock opportunities.

• Wellbeing support.

• Retirement and financial protection benefits.

• Comprehensive medical, dental, vision, life, and disability insurance options.

• Flexible Time Off (FTO) policy without a set accrual limit for eligible U.S.-based exempt employees.

• 11 paid company holidays each year.

• 160 hours of paid vacation annually for eligible new hires.

• 3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees.

• Paid sick leave available based on eligibility.

• Up to two paid volunteer days per year.

• Flexible summer hours.

• Various types of leaves, including medical, personal, parental, caregiver, bereavement, and military.

• Annual Global Shutdown period between Christmas Day and New Year's Day.

• Workplace accommodations and ongoing support for individuals with disabilities.