Note: The job is a remote job and is open to candidates in USA. Vita Global Sciences, a Kelly company, is seeking a Senior Clinical Research Associate for a long-term engagement supporting a global medical device client. The role focuses on clinical trial site management, study start-up, regulatory submissions, informed consent review, site activation, and enrollment authorization for complex cardiac studies.
Responsibilities
- Study Start-up:
- Contracts
- SM meets regularly (typically weekly) with the Contract Specialist for status update on contracting/budget negotiations for each sites
- SM reaches out to site as necessary (e.g. if site has been unresponsive with the Contract Specialist)
- SM provides contract/budget updates to study leadership on a regular basis
- EC Submission: SM provides regulatory documents to sites, including ICF to site for submission to EC
- ICF Review and approval (throughout trial): SM reviews initial draft site ICF (provided by site to SM) to confirm all study related requirements are included in the ICF; completes ICF checklist to confirm all required elements are included in ICF (ICF Checklist is complete prior to submission to EC and following approval from EC)
- Study Activation Checklist: SM complete SAC and sends document for signature by study lead
- Enrollment Activation Letter: SM sends site Enrollment Activation Letter, confirming site authorization for consenting participants into the study
Skills
- Candidates must have complex cardiac experience within the past 5 years , preferably in electrophysiology and / or devices
- • CRA training or bridge program through a reputable organization / employer
- • Clinical background
- • In-depth knowledge of applicable regulations and ICH/GCP guidelines
- • Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly
- • Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams
- • Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely
- • Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment
- • Ability to work independently and manage multiple priorities in a dynamic environment
- • A well-executed plan for communication with the study teams and sites
- • Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports
Benefits
- This is a remote based opportunity.
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