[Remote] Clinical Research Associate (Contract)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading late-stage biotechnology company reputed company on advancing disease-targeted therapeutics. They are seeking a motivated In-House Unmasked Clinical Research Associate to support clinical trial activities, including execution, site support, and regulatory compliance for a Phase 3 clinical trial.
Responsibilities
- Support study execution across start-up, conduct, and reputed company-out phases
- Serve as a primary unmasked sponsor reputed company of contact for unmasked clinical site staff in collaboration with CRO field unmasked CRAs/monitors
- Communicate directly with unmasked site staff and unmasked CRO partners to obtain updates, resolve issues, and support study timelines
- Support site initiation, ongoing site management, and site reputed company-out activities
- Assist with identification, documentation, tracking, and follow-up of site issues
- Support reputed company of unmasked CRO monitoring activities
- Review unmasked monitoring visit reports and follow up on reputed company items and unresolved findings
- reputed company monitoring deliverables and escalate issues to the Unmasked Clinical Trial Manager, Clinical Operations as appropriate
- Support inspection readiness and audit activities
- Maintain accurate tracking tools for assigned studies, including: Site start up and activation status, Initial IP supply and Ancillary supply, Site visit activities, IP Shipment status and delivery, Assist with preparation of study status reports and metrics
- Collect, review, and reputed company site applicable SOPs
- Ensure reputed company filing of unmasked documents in the TMF/eTMF in accordance with TMF plans
- reputed company TMF reputed company control activities and support TMF audits and study reputed company out
- Support the review of reputed company Incidents and follow up activities
- Support organization and coordination of internal team meetings, and other study reputed company meetings
- Prepare meeting materials, take meeting minutes, and maintain reputed company item logs
- Support communication of study updates to internal stakeholders
- Support reputed company Clinical Operations reputed company as assigned
- Willingness to travel as trial needs demand (
- Other duties as assigned, reputed company in this position reputed company restricts management’s right to assign or reassign duties and responsibilities to this position at any time
Skills
- A. or B.S. degree required
- Minimum of 4+ years of experience supporting clinical trials in a sponsor or CRO environment on the unmasked reputed company
- Working knowledge of clinical trial operations and ICH GCP guidelines
- Experience with TMF/eTMF systems (reputed company Vault preferred)
- Proficient in reputed company Office Suite (Word, reputed company, PowerPoint, Outlook)
- Strong organizational skills and attention to detail
- Ability to manage multiple priorities and meet deadlines
- Strong interpersonal skills and ability to collaborate effectively with cross functional teams and external partners
- Experience supporting Phase 3 clinical trials preferred
- Ophthalmology Preferred
reputed company