Job Title

SUMMARY OF POSITION: The Clinical Research Coordinator (Utility) works under the direction of the Research Lead, Medical Director, and Principal Investigator to coordinate clinical studies as assigned. The CRC will be responsible for document preparation and submission to the IRB; direct interaction and managing care of patients with memory disorders; oncology patients; Pulmonology patients, and any new areas the we may open. Working with patient caregivers; obtaining and documenting informed consent as per FDA & ICH/GCP Guidelines; data entry and query resolution; assisting in training and credentialing of research staff; ensuring that SOPs, research protocols, and regulatory requirements are followed. JOB RESPONSIBILITIES: Participate in the implementation and management of clinical trials including but not limited to pre-site visits, IRB submission, principal investigator communication, site initiation visits, patient screening, accrual and follow-up, informed consents, monitor visits, case report form submissions, and reporting of severe adverse eventsAssure adherence to SOPs, good clinical practice, and FDA regulationsWork to ensure all IRB required submissions are submitted according to regulationsRecord accurate and timely data onto case report forms according to protocol/sponsor requirements Plan and implement pre-study activities on assigned trials by developing timelines for conducting and completing the clinical protocolParticipate in patient screening, recruitment, enrollment and follow-up of assigned clinical trialsDevelop systems to aid in meeting accrual goalsResolve protocol queries as assignedParticipate in scheduling and coordinating pre-study site visits, initiation visits, and monitoring visitsObtain informed consent, randomize patient according to protocol, schedule patient visits/tests and assess/document toxicities and adverse effectsPerform Vital Signs, including measurement of study subject's weight, height, blood pressure, heart rate, temperature, oxygen saturation, and respirations according to study protocol Obtain blood and urine samples from study subjects and process according to study protocol and IATA specifications Retrieve specimens from pathology department and prepare for shipment according to study protocol and IATA specificationsPrepare study subject and perform ECGs according to study protocolAdminister and rate Cognitive Scales and Assessments as required by study protocolAssess patient compliance with study procedures and report any deviations to Lead Clinical Care Coordinator and sponsorDocument protocol deviations and SAE'sDispense investigational product and maintain accountability logsMaintain source documentation filesWork with monitors during visits to correct any data errors and answer queriesEducate research staff and investigators on protocol specifics, investigational product, and other necessary itemsSupport the activities of the principal investigators / sub-investigatorsCommunicate effectively with physicians, patients, IRB, monitors, contract research organizations, and sponsors utilizing good interpersonal skills regarding the status of current and potential clinical trialsCommunicate with Clinical Research Manager on a regular basis concerning study accrual, screening numbers, monitoring visits, etc.Participate in the orientation and training of new staff involved in the implementation and management of clinical trialsParticipate in the development and management of quality assurance and performance improvement activities within the programJOB SPECIFICATIONS: Minimum QualificationsGraduate of an accredited college or university with a bachelor's degree of science. (nursing degree accepted but not required)Experience with GCP and regulatory requirementsExperience administering and rating Cognitive Scales/Assessments Perform venipuncture and ECGs Processing laboratory and pathology samples as required per study protocol Preferred Experience & Skills1+ years experience in clinical research2+ years experience in data management and data management softwareACRP (Association of Clinical Research Professionals), or SoCRA (Society of Clinical Research Associates)Ability to anticipate and timely escalate potential issues to leadershipAbility to manage multiple tasks and prioritize accordinglyAct as a team player with positive attitude and excellent interpersonal skillsProficient in using Microsoft Excel, Word, and PowerPointAbility to gather, organize, and verify data for projectsAbility to maintain attention to detail to avoid errors of a technical or judgmental natureMaintain confidentiality of data and patient information according to HIPPA regulations