Clinical Research Coordinator

About Istios HealthIstios Health is a national, specialty network that strengthens specialty care delivery and expands access to clinical research where patients are treated every day. The company partners with independent specialists, healthcare facilities, and life sciences organizations to connect and scale clinical expertise, real-world evidence, telehealth, and research infrastructure in an integrated model. Key Responsibilities:This is a full-time, on-site role. Under the direction of the Senior Director of Clinical Research and the Principal/Sub Investigator(s):Coordinates with Principal Investigator, local site, and Istios Health to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines and Istios Health’s SOPs.Adhere to clinical trial protocols and coordinate and perform assigned clinical trial activities including, but not limited to:Participant pre-screening, recruitment and schedulingComplete protocol and trial system trainingMaintenance 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 visitsEntering 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 deviationsMaintains adequate inventory of study suppliesCoordinates appropriate and timely payments to participantsManages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsorCommunicate effectively and professionally with coworkers, leadership, trial participants, sponsors, CROs, and vendors.Apply good documentation practices in accordance with ALCOA-C standards when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queriesTrack screening and enrollment status of patients in site systems and ensure timely communication with patients regarding their study participationUnderstand thoroughly all assigned studies through reading protocols an completing assigned trainings, including preparing for attending site initiation visits (SIV’s) and Investigator Meetings (IMs), as neededMay set up, train and maintain all technology needed for studiesAdheres to and supports all Federal regulations and company policies and procedures instituted to safeguard protected health information (PHI)Perform other duties as assignedAbility to perform basic lab and clinical procedures per protocol, such as: blood specimen collection (phlebotomy)blood pressurevitalsEKGscentrifuge operationstoring and shipping of lab specimensaccountability of specimens and notification of courier for specimen pick-upQualificationsCollege degree (health sciences) preferred or significant relevant experience At least 2 years of CRC experience in a direct patient care roleKnowledge of Good Clinical Practice (GCP), IATA and FDA regulations pertaining to clinical trialsFluent in written and spoken EnglishAbility to complete clinical procedures including phlebotomy, vitals, height, weight, ECGs