Clinical Research Coordinator

THIS POSITION IS 100% ONSITE AND IS NOT A REMOTE OR HYBRID POSITIONClinical Research Coordinator experience is required. OverviewThe Clinical Research Coordinator (CRC) is responsible for overseeing various aspects of clinical research studies from enrollment through closeout. The CRC will manage the day-to-day responsibilities of enrolling participants into clinical research studies, ensuring enrollment goals are met and data entry and query resolution are completed in a timely manner. The CRC will work in close proximity with the Associate Director of Clinical Research, the Investigators, and other Research Staff, and sponsor/CRO representatives to carry out the clinical trials within the organization.ResponsibilitiesUnderstand the recruitment plan, assist senior level CRCs to lead pre-screening and recruitment efforts, and ensure enrollment goals are met for each assigned trial.Speak to potential participants to gauge their interest in participating in a trial.Create and update source documents for assigned trialsSchedule participants for study visits, ensuring scheduling occurs in the CTMS and EMR.Travel to and attend Investigator Meetings, conferences, and other research-related meetings, as requested.Assist the PI by creating training logs and materials to ensure all staff and investigators are properly trained and delegated prior to completing any trial-related tasks.Review and understand each assigned protocol, including the Inclusion/Exclusion Criteria, study visits, timelines, and be able to navigate the protocol for vital information when needed.Assist the PI with maintaining documentation of IP inventory for each assigned trial.Maintain adequate inventory of study supplies.Build rapport with study participants to encourage compliance with study procedures and facilitate retention throughout the entire duration of the study.Enter all visits and invoiceable items into the CTMS in a timely manner.Work closely with investigators, ensuring they are kept up to date on participants.Act as a liaison between the investigator and the sponsor, ensuring all communications and information are relayed to the investigator with quick turnaround responses to the sponsor when information is requested.Prepare and submit documents and reports to the Institutional Review Board (IRB) as required by the protocol and federal regulations and guidelines.Perform study tasks as delegated on the Delegation of Authority Log for each trial, including, but not limited to: Obtaining and recording medical history, concomitant medications, Adverse Events and Serious Adverse Events, vital signs; performing all clinical and administrative tasks related to visitsDeliver high quality data by completing source documents accurately and fully at each participant’s visit.Complete data entry and resolve queries in a timely manner.Request, review, and extract information from medical records throughout the trialsAccurately record and register participants and their information into the study systems such as the Interactive Response Technology (IRT) and Electronic Data Capture (EDC) systems.Coordinate interim monitoring visits and closeout visits, ensuring all data, source, and regulatory items are completed, filed, and available for sponsor/CRO representatives, and ensuring that the PI is available to meet with the sponsor/CRO representative at each visit.Review Interim Monitoring Visit Follow-up Letters and correspondence from sponsors/CROs, complete action items, and communicate professionally and responsively to sponsor/CRO representatives throughout the trial in a timely manner.Report delays, issues, or problems as they occur for assigned trials to the Associate Director of Clinical Research, helping to formulate a solution to reported delays, issues, or problems.Cooperate with compliance efforts and report instances of non-compliance to the Associate Director of Clinical ResearchUpload, file, and maintain eISF for each assigned trial, ensuring documents are kept current and files are complete.Prepare for and participate in inspections, audits, and other regulatory checks by sponsors, CROs, and other regulatory agencies.Provide mentoring to Research AssistantsParticipate in company training and meetings, as needed.Support and model teamwork and a positive work environment at the site(s).Perform other job-related duties as requested and required.SkillsSuperior communication and organizational skillsExtensive knowledge of medical terminologyKnowledgeable and experienced with Good Clinical Practice, ICH Guidelines, and HIPAA within clinical trialsStrong work ethic and ability to quickly establish rapport with participants, investigators, and sponsor/CRO representative.Proficient in the use of Microsoft Office SuiteMeticulous attention to detail with the ability to multi-taskCapable of establishing and maintaining working relationships with colleagues, patients, sponsors, and other clientsJoin us in our mission to drive innovation through research!Job Type: Full-timeBenefits:401(k)401(k) matchingDental insuranceFlexible spending accountHealth insuranceLife insurancePaid time offVision insuranceWork Location: In person