Lead, Clinical Research Associate
New
J
JobgetherClinical Research
Based in United StatesFull-TimeLead
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 5 years of experience in clinical operations or a related discipline within a CRO or pharmaceutical environment, including a minimum of 3 years of on-site monitoring experience.
- Required Skills
- Project ManagementPeople ManagementMentoring
Requirements
- Bachelor’s degree in a biomedical, life sciences, or related discipline, or equivalent professional experience.
- At least 5 years of experience in clinical operations or a related discipline within a CRO or pharmaceutical environment.
- Minimum of 3 years of on-site monitoring experience.
- Demonstrated people-management experience, including the ability to lead, mentor, coach, and develop clinical research professionals.
- Strong knowledge of Good Clinical Practice (GCP) and 21 CFR Part 11.
- Hands-on experience conducting Feasibility Assessments, Site Qualification, Initiation, Routine Monitoring, and Close-Out visits.
- Experience with investigational product accountability, Trial Master File (TMF) maintenance, and safety reporting/SAE handling.
- Excellent written and verbal English communication skills.
- Strong organization, analytical judgment, multitasking, and time-management abilities.
- Ability to maintain strict confidentiality of subject data and sponsor/client information.
- Flexible and willing to travel for planned and occasional short-notice meetings and site visits.
Responsibilities
- Lead, supervise, mentor, and coach Clinical Research Associates and contractors to ensure adherence to organizational policies and quality standards.
- Support the recruitment, onboarding, training, and professional development of team members.
- Coordinate resource allocation, assign projects, and monitor CRA workloads to ensure timely delivery.
- Act as an escalation point for direct reports to resolve operational challenges, deviations, and quality issues.
- Oversee clinical study implementation to ensure compliance with protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Perform co-monitoring or direct site monitoring activities on selected studies as required.
- Review monitoring metrics and deliverables to identify quality trends and implement corrective actions.
- Collaborate with sponsors, project managers, and investigators to resolve study issues and maintain project momentum.
- Participate in audits and regulatory inspections, including preparation and follow-up activities.
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