CRO – Contract Clinical Research Associate
Evolution Research Group
contract
Posted on:
Location Type: Remote
Location: Texas • United States
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Tech Stack
About the role
- Conduct site monitoring responsibilities for Clinical trials, according to Standard Operating Procedures, ICH guidelines, and GCP.
- Manage and monitor site activities for assigned clinical studies, working individually or co-monitoring with other Clinical Research Associates (CRAs).
- Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits.
- Ensure compliance with the protocol and applicable Company or Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines.
- Perform site evaluation visits of potential investigators.
- Evaluate the capability of the site to successfully manage and conduct the clinical study.
- Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities.
- Assist in resolving any issues to ensure compliance with site file audits.
- Direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management.
- Document accountability, stability and storage conditions of clinical trial materials as required by sponsor.
- Perform investigational product inventory. Ensure return of unused materials to designated location or verify destruction as required.
- Serve as primary contact with the site; coordinate all correspondence; ensure timely transmission of clinical data with the study site.
- Perform study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
- Ensure internal and study-related trainings are completed per Lotus and/or study timelines.
- Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan (MP) for Confirmation Letters, Follow up Letters and Monitoring Visit Reports (MVR).
Requirements
- Ability and willingness to travel up to 75% of the time (land and air).
- College degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- In lieu of the university /college degree or certification requirement, a minimum of 5 years of relevant clinical research experience in health care, pharmaceutical, or CRO settings may be considered and minimum of 2 years field monitoring experience as a CRA.
- Phase I experience preferred
- Preferred therapeutic areas: Substance Abuse, MAD/SAD, Hepatic, Impairment, Chronic Pain and Bipolar/Depression.
- Valid Driver’s License.
- Legally authorized to work in the US.
Benefits
- Post-operative pain experience required
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial monitoringsite qualificationsite initiationinterim monitoringclose-out visitscase report form completioninvestigational product inventorydata query resolutionstudy close-out activitiescompliance with FDA regulations
Soft Skills
communicationproblem-solvingorganizational skillsteam collaborationtraining abilitiesattention to detailtime managementadaptabilityinterpersonal skillsconflict resolution
Certifications
nursing licensureclinical research certification