Clinical Research Coordinator 248011

We are looking to add a Clinical Research Professional to a growing team. If you are looking for join a company with great culture and a work life balance, this is a great opportunity for you.OverviewThe CRC is responsible for the day-to-day operations of clinical trials at the site which include coordinating participant visits, recruiting and retaining trial participants, and performing tasks as delegated, required to complete a study according to the protocol and ICH-GCP guidelines.Key ResponsibilitiesCoordinates with Principal Investigator, and local site, to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines and SOPs.Adhere to clinical trial protocols and coordinate and perform assigned clinical trial activities including, but not limited to:Participant pre-screening, recruitment and schedulingMaintenance of regulatory documentsConducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study.Conducting participant visitsAbility to perform basic lab and clinical procedures per protocol, such as: Blood specimen collection (phlebotomy) and Centrifuge operationBlood pressure, Vitals, EKGsStoring and shipping of lab specimensEntering data in the EDC and resolving all queriesUpdating and maintaining trial logs and participant chartsConducting monitoring visits and resolving issues as needed in a timely mannerManaging and reporting of AEs, SAEs, and deviationsManages and maintains all regulatory information about the study including theprotocol, investigator brochure, IRB documents, Investigator disclosures, CVs, trainingdocumentation, instructions on reporting requirements for the IRB and the sponsorCommunicate effectively and professionally with coworkers, leadership, trial participants, sponsors, CROs, and vendors.Track screening and enrollment status of patients in site systems and ensure timely communication with patients regarding their study participationQualificationsCollege degree (health sciences) preferred or significant relevant experienceAt least 2 years of CRC experience in a direct patient care roleKnowledge of Good Clinical Practice (GCP), IATA and FDA regulations pertaining to clinical trials