Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.

Requirements

Bachelor's Degree in scientific discipline or health care preferred.
Requires at least 2 years of on-site monitoring experience.
Equivalent combination of education, training and experience may be accepted in lieu of degree.
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Good therapeutic and protocol knowledge as provided in company training.

Benefits

Health insurance
Retirement plans
Paid time off
Flexible work arrangements

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

site monitoringstudy managementdata query generationregulatory submissionscase report form (CRF) completionprotocol trainingstudy documentationsubject recruitment planningquality evaluationproject execution support

Soft Skills

communicationcollaborationproblem-solvingorganizational skillsadaptability

Certifications

Good Clinical Practice (GCP)International Conference on Harmonization (ICH)