Performs all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits
Trains investigator(s) and site staff on study protocol and all relevant study procedures
Supports study start-up, conduct, and closeout activities.
May assist in developing study related plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, reviewing informed consent forms, monitoring plan, etc.
May coordinate IRB/EC approvals
Functions independently in the field and interacts professionally with all levels of medical and scientific professionals
Identify early on any unsatisfactory results, operations or specific problems and take immediate action to appropriate groups including escalating and assisting in resolving any study related issues that arise during study conduct
Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits
Responsible for implementing and maintaining the effectiveness of the quality system
Collect and review site regulatory and essential documents for accuracy and completion
Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained
Perform Source Data Verification (SDV) and data cleaning in accordance with study monitoring plan
Reviewing all study logs and documentation ensuring audit trail and chain of custody is maintained
Performs Investigation Use Only (IUO) or Research Use Only (RUO) inventory and accountability, in accordance with study monitoring plan
Facilitates return or destruction of any unused IUO/RUO material as required
Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings
Maintains accurate and timely communications with sites and ensures records are filed in TMF/ISF
Ensures TMF/ISF is audit ready
Assists with site audit(s) and site quality management activities, as needed
Tracks site progress against contractual agreements
Contribute to organizational and departmental process development, improvement, and implementation
May serve as Lead CRA or Lead monitor for assigned studies
Works closely with other assigned CRAs to track monitoring deliverables and metrics in accordance with the study monitoring plan

Requirements

Bachelor's degree in biological sciences or medical specialty or higher, or equivalent credentials
5+ years direct clinical research experience at a sponsor, device manufacturer, IVD, companion diagnostics as a CRA/study monitor, or equivalent experience
Experience with Electronic Data Capture (EDC) systems and eTMF systems
Previous experience with Next Generation Sequencing (NGS), lmmunohistochemistry (IHC), and/or pathology
Knowledge of International Council for Harmonisation (ICH)/GCP guidelines, 21 CFR (Code of Federal Regulations) part 812 (lnvestigational Device Exemption) (IDE)), and monitoring procedures/best practices (ICH E6(R2))
Demonstrating strong written and verbal communication skills and presentation skills
Track record demonstrating strong organizational and problem-solving skills
Track record demonstrating a strong work ethic and ability to deliver tasks on time
Proficient with Microsoft Office Suite including automation tools

Benefits

eligibility for bonus
stock
benefits

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical researchstudy monitoringSource Data Verification (SDV)data cleaningclinical protocol developmentregulatory document reviewmonitoring planNext Generation Sequencing (NGS)Immunohistochemistry (IHC)Electronic Data Capture (EDC)

Soft Skills

communication skillsorganizational skillsproblem-solving skillswork ethicpresentation skills

Certifications

Bachelor's degree in biological sciencesBachelor's degree in medical specialtyequivalent credentials