Clinical Research Associate Lead
3 weeks ago
We are looking for an experienced Clinical Research Associate Lead to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT. The ideal candidate will have a strong background in clinical research, with a minimum of 7 years' experience as a CRA/Monitor. They will be responsible for conducting monitoring visits at clinical trial sites and overseeing the activities of co-monitors.
The salary range for this position is $122,000 to $145,000, with a midpoint of $131,000. The successful candidate will be able to travel approximately 65% of the time.
About the Position
The Clinical Research Associate Lead (CRA) is responsible for conducting monitoring visits at clinical trial sites and conducting site management activities. This position works closely with the leads of the sub-functions of clinical operations, data management, pharmacovigilance, other functions, and service providers involved in the day-to-day clinical trial execution activities.
- Actively participate in all aspects of clinical trial operations, including independently conducting pre-study/qualification, initiation, interim, and close-out visits at assigned clinical trial sites.
- Conduct site management activities between monitoring visits for assigned clinical trial sites.
- Participate in the generation of monitoring document templates, monitoring SOPs, clinical trial plans, study logs, study forms, and other study specific documents.
- Complete monitoring visit documentation per plans and applicable SOPs.
- Reconcile the electronic trial master file with the investigator site file.
- Re-train site staff on therapeutic area, protocol requirements, proper source documentation, case report form completion, and investigational product handling requirements as needed throughout the study.
- Provide site feedback to internal team members.
- Implement action plans for sites not meeting expectations.
- Mentor junior CRAs and CTAs.
- Oversee the activities of co-monitors for assigned clinical trial sites.
- Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
- Other tasks and responsibilities as needed.
- Supervisory Responsibilities: None
- Ability to travel approximately 65%.
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