Company
Biotech
SeniorClinicalResearchAssociate
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Clinical Research Associate. Skills: Clinical trial methodology, Regulatory frameworks, ICH-GCP guidelines, Site management. Serve as primary point of contact. Ensure protocol adherence”
What You'll Achieve.
Improving patient care; Improving treatment outcomes
Industry & Context.
Problem-solving; Analytical
Willingness to travel extensively
What They're Looking For.
Must Have
Degree in biological sciences, Degree in pharmacy, Degree in nursing, Degree in health discipline, Equivalent professional experience, Ability to work independently, Manage priorities, Make sound decisions, Proficiency with clinical systems, Proficiency with CTMS, Proficiency with EDC, Proficiency with electronic document management tools, Proficiency with MS Office applications
Nice to Have
Experience in site management, Experience in clinical research, Understanding of clinical trial methodology, Understanding of regulatory frameworks, Understanding of ICH-GCP guidelines
What You'll Do.
Serve as primary point of contact
Ensure protocol adherence
Ensure operational compliance
Ensure high-quality study execution
Conduct remote contacts
Evaluate site performance
Support ongoing study activities
Build relationships with investigators
Build relationships with site staff
Provide training to sites
Provide guidance to sites
Provide ongoing support to sites
Monitor data integrity
Ensure data integrity
Address data quality concerns
Oversee site documentation
Ensure audit readiness
Ensure inspection readiness
Assess site recruitment strategies
Assess study progress
Assess site performance
Recommend corrective actions
Recommend improvements
Ensure ICH-GCP compliance
Ensure local regulations compliance
Ensure study-specific procedures compliance
How You'll Work.
Team & Collaboration
Internal teams; Clinical sites; Site teams; Global clinical teams
Communication Scope
Communication; Interpersonal
Full Job Description
## Accountabilities Serve as the primary point of contact for assigned clinical trial sites, ensuring protocol adherence, operational compliance, and high-quality study execution from initiation through close-out. Conduct site visits (qualification, initiation, monitoring, and close-out) as well as remote contacts to evaluate site performance, resolve issues, and support ongoing study activities. Build and maintain strong relationships with investigators and site staff while providing training, guidance, and ongoing support to ensure regulatory and procedural compliance. Monitor and ensure data integrity by reviewing CRFs, resolving queries, tracking SAEs, and addressing any data quality concerns in collaboration with site teams. Oversee site documentation, including regulatory files and TMF contributions, ensuring audit and inspection readiness at all times. Assess site recruitment strategies, study progress, and performance, recommending corrective actions and improvements where needed. Ensure compliance with ICH-GCP, local regulations, and study-specific procedures while identifying and escalating risks impacting timelines or data quality. Requirements: Solid experience in site management or clinical research, with strong understanding of clinical trial methodology, regulatory frameworks, and ICH-GCP guidelines. Degree in biological sciences, pharmacy, nursing, or a related health discipline, or equivalent professional experience. Strong ability to work independently, manage priorities, and make sound decisions in a fast-paced, matrixed environment. Excellent communication, interpersonal, and stakeholder management skills, with the ability to interact effectively with clinical sites and internal teams. Strong analytical, problem-solving, and attention-to-detail skills with a focus on data quality and compliance. Proficiency with clinical systems such as CTMS, EDC, and electronic document management tools, along with MS Office applications. Willingness to travel e
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