-
Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
-
Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.
-
Ensures appropriate and timely investigator site visits.
-
Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
-
Assists in development of study-specific Monitoring Plans and training presentations as required.
-
Assists in set up/collection of site specific ethics documents and site contract negotiation as required.
-
Provides monthly billing information to finance team as required.
-
For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.
-
Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.
-
Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
-
Ensures integrity of CRF data through meticulous and thorough source document review and verification.
-
Performs quality control and verification of documents collected at sites for eTMF/TMF.
-
Conducts investigational product accountability.
-
Reviews site regulatory binder for required documents.
-
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
-
Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
-
Participates in internal, client/sponsor, scientific, and other meetings as required.
-
Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
-
Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
-
Proactively identifies site issues and develops problem-solving strategies for sites.
-
Conducts audit preparation at study sites as needed.
-
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
-
Participates in internal, client/sponsor, scientific, and other meetings as required.
-
Assists in CRA new hire training and onboarding.
-
Performs CRA mentoring.
-
Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
-
Manages and resolves conflicting priorities to deliver on commitments.
-
Performs additional duties as assigned.
