Clinical Trial Site Monitor (contractor, temporary, remote)

Position Overview

Accelerated Cure Project, Inc. (ACP) is seeking a part-time Site Monitor for the CAFE-MS (Confirmatory Trial for Alleviating FatiguE in Multiple Sclerosis) clinical trial. The Site Monitor will play a crucial role in ensuring the integrity, compliance, and safety of the trial by monitoring all aspects at the site level, with a focus on centralized monitoring techniques for this decentralized clinical trial.

Trial monitoring is designed to ensure that:

• The rights and well-being of human subjects are protected
• The reported trial data are accurate, complete, and verifiable from the source electronic data collection platform
• The conduct of the trial complies with the protocol, Good Clinical Practice (GCP), and regulatory requirements

Position Details

• Part-time, temporary, non-staff position (estimated 192 hours/year), immediate start date, ~ 3 year duration
• 1099 contractor status
• Fully remote work
• Compensation: $35/hour, paid bi-weekly following submission of invoice
• Contractor is required to submit a W-9 form with tax ID/social security number
• Contractor is responsible for all deductions and taxes

Key Responsibilities

The Site Monitor will review and report on the compliance of six trial sites (the iConquerMS people-powered research network, and five VA Centers) for the CAFÉ-MS trial.

Specific responsibilities include, among others:

• Centralized Monitoring: Conduct quarterly remote monitoring activities using centralized data review techniques appropriate for decentralized clinical trials.
• Regulatory Compliance: Ensure adherence to all relevant regulatory standards and Good Clinical Practice (GCP) guidelines.
• Reporting: Provide detailed reports to the study sponsor regarding each site's progress, findings, and any identified concerns based on centralized data review.
• Protocol Adherence: Ensure strict adherence to the established clinical trial protocol at all study sites.
• Informed Consent: Verify that informed consent forms are properly obtained from participants and comply with ethical guidelines.
• Data Integrity: Review source documents and case report forms (CRFs) to verify the accuracy and completeness of collected data.
• Adverse Event Oversight: Review and verify the proper reporting and handling of adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs) by the study sites, ensuring compliance with protocol and regulatory requirements.
• Data Analysis: Perform remote evaluation of accumulating data in the centralized database, working with de-identified participant information.

Specific Monitoring Activities

• Conduct the first online monitoring Central Database "visit" for each site within 2 weeks of the completion of the baseline questionnaires of an Eligible Trial Candidate recruited by that site.
• Perform subsequent online monitoring Central Database visits for each site every 90 +/-7 days.
• Verify the availability of regulatory documentation for each site.
• Review 100% of the records of completion of training of site personnel.
• Review 100% of Trial Participants' Eligibility Criteria.
• Review 100% of the Site Log records of site Clinical Trial Coordinators (CTCs) contacting Eligible Trial Candidates or Trial Participants whose data is missing or incomplete.
• Review 100% of the Site Log records of actions on Trial Participant-reported Suspected Unexpected Serious Adverse Reactions/Serious Adverse Events/Adverse Events (SUSARs/SAEs/AEs) since the previous online monitoring visit.
• Verify that all AEs, SAEs, and SUSARs have been reported to the appropriate regulatory agencies as required.
• Confirm that the site has and will continue to meet safety reporting requirements.
• Review 100% of the Chalder Fatigue Scale (CFS) data of Trial Participants to identify participants whose CFS scores have worsened substantially and consistently during the trial.

Qualifications

• Bachelor's degree in a life science, healthcare, or related field (e.g., biology, nursing, medical sciences)
• Substantial clinical research experience, including knowledge of Good Clinical Practice (GCP) guidelines
• Certification from a recognized organization such as the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) is preferred
• Prior experience in monitoring or study coordination roles
• Thorough understanding of regulatory requirements and clinical trial protocols
• Strong data analysis skills and attention to detail
• Excellent communication and interpersonal abilities
• Experience with centralized monitoring techniques for decentralized clinical trials
• Ability to work with de-identified data, ensuring data privacy and integrity
• Familiarity with online trial portals and remote data collection methods
• Ability to work independently and manage time effectively
• Experience in preparing comprehensive monitoring reports and presenting results using analytical and visualization methods

Qualified candidates who are passionate about clinical research, experienced in centralized monitoring techniques, and committed to maintaining the highest standards of trial conduct in decentralized studies are encouraged to apply by submitting a cover letter and resume. Join us in contributing to the important CAFE-MS clinical trial and advancing medical research through innovative monitoring approaches.