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Senior Clinical Research Specialist
2 months ago
This role is fully remote.
Senior Clinical Research Associate - Direct Hire Opportunity
Remote position with travel responsibilities
Candidate must possess a Bachelor's degree in a scientific field along with a minimum of 1.5 years of site monitoring experience in clinical research as a Clinical Research Associate (CRA). The role requires the ability to travel to designated sites within an assigned region (South, Southeastern, Northeastern, West, etc.).
Salary is negotiable.
(Sponsorship is not available)
To apply, please submit your resume.
Responsibilities include:
- Conducting qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites while generating comprehensive visit/contact reports.
- Ensuring the integrity of the study and employing problem-solving skills to foster strong relationships with site personnel.
- Reviewing trial performance at designated sites to ensure the rights and welfare of human subjects are protected and in alignment with the study protocol.
- Developing patient recruitment strategies in collaboration with clinical sites to meet enrollment goals while ensuring adherence to approved SOPs, protocols/amendments, GCP, and applicable regulatory standards.
- Assessing the quality and integrity of reported data, site efficacy, and drug accountability.
- Monitoring the completeness and quality of regulatory documentation and performing verification of site documents.
Qualifications required:
- Bachelor's degree in a scientific discipline.
- A minimum of 1.5 years of monitoring experience in clinical research as a Clinical Research Associate (CRA).
- Ability to work independently with a sense of urgency and minimal oversight.
- Capability to manage multiple tasks, assess various unpredictable scenarios, and meet project timelines while applying knowledge of study protocols.
- Proficient computer skills, including familiarity with CTMS, EDMS, and MS Excel and Word.
- A client-focused approach with a flexible attitude towards assignments and a willingness to learn.
