Lead CRA

THE LEAD CLINICAL RESEARCH ASSOCIATE (CRA) ROLE. The Lead CRA provides oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality. Lead CRAs work closely with Director of Clinical Monitoring, In-house CRAs, field CRAs, and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Job DescriptionESSENTIAL JOB FUNCTIONS*Provides guidance, oversight, and feedback to the field CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirementsMonitors performance of field CRAs on a continuous basis, including reviewing monitoring visit reports and conducting co-monitoring visits as neededEnsures appropriate and timely investigator site visitsCoordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issuesAssists in development of study-specific Clinical Monitoring Plans and training presentationsAssists Director, Clinical Monitoring in resourcing field CRAs for planned and ongoing clinical trialsSupports field CRA hiring through initial screening, phone, and video interviews of potential new employeesResponsible for field CRA new hire training and onboardingConducts review of field CRA time and expenses, as appropriateProvides monthly billing information to finance teamPerforms qualification, initiation, interim, and close-out visits and ensures proper documentation of monitoring visitsPrepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment statusEnsures integrity of CRF data through meticulous and thorough source document review and verificationConducts investigational product accountabilityReviews site regulatory binder for required documentsMaintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requestsComplies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPsParticipates in internal, client/sponsor, scientific, and other meetings as requiredPerforms additional duties as assignedPREPARATION, KNOWLEDGE, SKILLS & ABILITIES BS/BA from an undergraduate program (life sciences or related discipline preferred)4 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 years’ experience in clinical monitoring with 1 year of management experienceProven ability to be careful, thorough, and detail-orientedStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environmentStrong analytical, negotiation, meeting management, cross-functional team, and leadership skillsAbility to problem-solve unstructured or ambiguous challengesStrong command of English, both written and verbalExcellent communication and interpersonal skills with customer service orientationProficient with MS Office Suite, particularly Word and ExcelSelf-starter who thrives in a collaborative, yet less structured team environmentPermanent authorization to work in the U.S.