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WEP Clinical · 4 days ago

Clinical Research Associate

United States

Full-time

Remote

Entry Level

1+ years exp

WEP Clinical is dedicated to advancing medical research and helping patients gain early access to therapies. As a Clinical Research Associate, you will support clinical trials through monitoring and compliance, ensuring all processes meet regulatory standards.

BiotechnologyInformation TechnologyPharmaceutical

Responsibilities

Schedule and perform on-site or remote monitoring visit activities, inclusive of the following study visit types: Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) / Routine Monitoring Visit (RMV), and Close Out Visit (COV)

Contribute to the development of protocols, study tools, materials, and documentation for clinical sites

Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed

Review site-level investigational drug accountability and safety event documentation

Review and verify patient files and records, informed consent, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies; provide training and/or initiate corrective action as required

Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan

Manage query resolution

Provide mentoring, training, and co-monitoring of junior team members

Assist in the development of applicable WEP Clinical Standard Operating Procedures

Develop applicable document templates, including (but not limited to), Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs

Complete, review, and/or submit monitoring reports and query logs

Address protocol or monitoring-related questions received from clinical sites for assigned programs

Qualification

Clinical monitoring experienceICH GCPEDC systems proficiencyLife sciences degreeOrganizational skillsProblem solverAnalytical skillsComputer literacyTeam playerDetail orientedWritten communicationVerbal communication