Job Details

DescriptionThis is an on-site role.Job DetailsDescriptionThis is an on-site role. Candidates must be local to Charleston, WV. Relocation assistance is not available.We are seeking an experienced Clinical Research Coordinator (CRC) to independently manage and execute clinical trials at the site level. This role is responsible for overseeing day-to-day study operations, regulatory compliance, patient coordination, and data management in accordance with protocol, GCP guidelines, and internal SOPs.Job PurposeCoordinate research and administrative procedures for the successful management of clinical trialsEnsure SOPs are followedPerform diverse administrative duties pertaining to clinical researchManage trial operationsEssential Functions/Responsibilities (other Duties May Be Assigned)Independently manage clinical trial operations from start-up through closeoutEnsure compliance with protocols, GCP, IRB, and regulatory requirementsCoordinate with investigators, sponsors, CROs, and IRBScreen, consent, and enroll study participantsMaintain accurate and timely source documentation, CRFs, and regulatory filesEnter and manage data in EDC systems and CTMSTrack subject enrollment, retention, and follow-upsReport adverse events (AEs/SAEs) within required timelinesPrepare for and support monitoring visits, audits, and inspectionsManage study supplies, equipment, and investigational product (IP)Maintain regulatory binders and study documentation in audit-ready conditionRequired Skills And ExperienceMinimum 2+ years of Clinical Research Coordinator (CRC) experience at a site levelHands-on experience with:EDC systems (e.g., Medidata, REDCap, etc.)IRB submissions (initial, continuing review, closures)Informed consent processAdverse event reportingStrong understanding of:Good Clinical Practice (GCP)FDA and regulatory guidelinesExperience managing multiple studies simultaneouslyAbility to work independently with minimal supervisionStrong attention to detail and documentation accuracyPreferred QualificationsBachelor's degree in Life Sciences, Healthcare, or related fieldExperience with CTMS systemsCurrent GCP certificationWhat Will Set You ApartExperience working directly with sponsors/CROsAbility to manage full study lifecycleStrong organizational and problem-solving skills in a fast-paced environmentBenefits OfferedHealth Insurance (Single & Family plans available)Life InsuranceDisability Insurance401(k) Plan with Company MatchEmployee Discount ProgramPaid Time OffPaid Holidays#J-18808-Ljbffr