Senior Clinical Research Associate
Jobgether · United States · 1 mo ago
RemoteRemoteResearchFull-time
Accountabilities
- Maintain accurate documentation and reporting related to monitoring activities and study progress.
- Contribute to continuous improvement initiatives within clinical research operations.
- Perform remote and on-site monitoring visits, including pre-study, initiation, interim, and close-out visits, to evaluate site readiness and ongoing study performance.
- Assess investigator qualifications, site resources, facilities, equipment, and staffing capabilities to ensure successful clinical trial execution.
- Monitor study activities to verify compliance with protocols, regulatory requirements, and quality standards.
- Identify potential risks, deviations, and operational issues, and collaborate with site teams to implement appropriate solutions.
- Support regulatory and ethics committee submissions when required.
- Build strong relationships with investigators, clinical site personnel, and internal teams through effective communication and collaboration.
- Provide training and guidance to investigational site staff as needed to support effective study conduct.
- Participate in mentoring and training activities for new team members, including co-monitoring visits to support performance development.
Requirements
- Experienced clinical research professional with strong monitoring expertise and the ability to manage complex studies in a dynamic environment.
- Bachelor’s degree or equivalent qualification in Life Sciences or a related discipline.
- Extensive experience conducting on-site monitoring activities for Phase II and Phase III clinical trials.
- Experience with complex clinical trials, preferably in oncology, rare disease, or other specialized therapeutic areas.
- Strong understanding of clinical trial processes, regulatory requirements, and site management practices.
- Full professional proficiency in English.
- Ability to independently plan, prioritize, and manage multiple responsibilities in a fast-paced environment.
- Strong communication, collaboration, organization, and problem-solving skills.
- Ability to build effective relationships with investigators, site teams, and cross-functional stakeholders.
- Willingness and ability to travel nationally as required.
Benefits
- Opportunity to contribute to meaningful clinical research programs that improve patient outcomes.
- Collaborative environment with experienced professionals across clinical research, safety, and quality disciplines.
- Exposure to innovative therapies and complex therapeutic areas.
- Opportunities for professional growth, mentoring, and continued development.
- Supportive culture focused on quality, integrity, collaboration, and patient impact.
- Opportunity to work within a global organization with diverse teams and perspectives.