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Description:
Lead CRA
CRA oversight- tracking metrics of 5-7 CRAs
Vendor Oversight
Responsible for 2 sites independently as well as oversight
Location: Mountain time
The candidate will be primarily responsible for assisting the Clinical Operations team in the execution of clinical trial deliverables in an effective and efficient manner. The candidate will be responsible oversight of investigational sites in the United States. This includes: overall site management, and monitoring (including start-up, initiation, routine monitoring, and close-out visits), monitoring inventory of ancillary supplies, file maintenance, and ensuring recruitment goals are met.
Requirements/Qualifications:
- At least 3 years as a full-time Lead regional monitor working for a sponsor or Contract Research Organization (CRO)
- Experience managing aspects of CRO functions is a plus
- Travel is required for the position, this may be extensive at times
- Experience managing serious adverse events in collaboration with safety surveillance. Ensuring events are being properly followed to completion
- Extensive experience collaborating/interacting with counterparts at sponsor and other CROs/vendors (laboratories, drug depots, etc.)
- Experience managing clinical trial investigational sites
- Conducting site feasibility assessments, participating in or managing the site selection process, analyzing patient recruitment and retention rates
- Organize and perform site initiation visits and site training activities
- Perform periodic monitoring visits
- Verify biological sample collection, storage, and shipping procedures at the site
- Verify laboratory data is reviewed by the investigator, properly captured in the case report form, and if necessary, is being reconciled properly within the CRF
- Organizing and monitoring investigator study files
- Preparing and organizing local institutional review board(IRB)/ethics committee (EC) submissions in collaboration with the site(s) and Clinical Trials Associates
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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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Full Time
$59k-76k (estimate)
01/13/2024
04/11/2024
The job skills required for Lead Clinical Research Associate include Clinical Trial, Clinical Trial Management System, Clinical Operations, Initiative, Collaboration, Data Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Lead Clinical Research Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Lead Clinical Research Associate. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Lead Clinical Research Associate positions, which can be used as a reference in future career path planning. As a Lead Clinical Research Associate, it can be promoted into senior positions as a Clinical Research Associate II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Lead Clinical Research Associate. You can explore the career advancement for a Lead Clinical Research Associate below and select your interested title to get hiring information.