Senior Clinical Research Associate
New
J
JobgetherClinical Research
Based in United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Full professional proficiency in English.
Requirements
- 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.
Responsibilities
- Perform remote and on-site monitoring visits, including pre-study, initiation, interim, and close-out visits.
- Assess investigator qualifications, site resources, facilities, equipment, and staffing capabilities.
- 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 solutions.
- Provide training and guidance to investigational site staff to support effective study conduct.
- Support regulatory and ethics committee submissions.
- Build relationships with investigators, clinical site personnel, and internal teams.
- Participate in mentoring and training activities for new team members.
- Maintain accurate documentation and reporting related to monitoring activities and study progress.
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