Clinical Research Coordinator

Benefits

Qualifications

• •Knowledge of medical terminology, clinical medicine, clinicaltrialsand GCP concepts
• •Detail-oriented and meticulous in all aspects of work with the ability to be flexible, organized, detail-oriented and tenacious in follow-through
• •Strong follow-through skills and ability to proactivelyidentifyand solve problems;demonstratedinitiative is imperative
• •Must have professional demeanor andstrong communicationskills with the public as well as physicians and researchers
• •Ability to work well independently as well as in a team environment
• •Must be proficient in Microsoft Office, electronic health systems and databases used ina researchenvironment orhave a willingness to learn anddemonstrateproficiencywithin six months of hire
• •Possess the ability to work well under pressure, multi-taskand manage deadlines
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Responsibilities

• •The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Principal Investigator (PI) and VP of Clinical Operations on multiple ongoing research studies
• •While the Principal Investigator isultimately responsiblefor the clinical trial, the CRCis responsible forthe facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study
• •The CRC works collaboratively with the entire Beacon Clinic team,sponsors, andsponsormonitors to ensure compliance with theprotocol, ensuringparticipant is receivingquality and safe care, along with productive andtimelydatasubmissions
• •Ensures assigned studies are conductedin accordance withthe Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) by way of reviewing and acknowledging all regulatory requirements to confirm implementation ofappropriate methods, practices, and procedures for all research activitieswhileutilizinggood clinical practice
• •Coordinates participant care throughout the research protocol continuumto include, but not limited toprescreening and screening for eligibility, confirming eligibility prior to randomization, consenting, coordination of all necessary protocol procedures and seeking problemresolutionsas necessary
• •Develops and implementsaccuratesource materials andensurescompliance from all applicable site staff
• •Providesaccurateandtimelydata collection documentation,dataentry, and reporting in both Beacon's EMR andsponsors applicable databases
• •Reports serious adverse events within 24 hours from site awareness of the eventin the applicable data system
• •Confirmsappropriate credentialingand trainingsare complete and current foraccuratedata captureregardingall study materials such as protocols, participants questionnaires, electronica data capture systems, collection, storage and shipment of specimens,and drug accountability per delegation of responsibility log
• •Supports the regulatory staff in the maintenance of regulatory documents,standard operating procedures,and applicable regulations
• •Communicates specific study requirements to the research team, including internal and external parties,sponsor, monitors, PI, and study participants
• •Participateswith principalinvestigatorand studyteamtoidentifyand prioritize the development of systems and infrastructure tomaintainresearch quality andcompliance
• •Monitorsresearch participants to ensure visits are appropriately scheduled and include all necessary components
• •Updatesresearch calendar and date spreadsheetto ensure it can be usedasanaccuratecommunication tool amongst the research team as well as advising whenassistanceis needed tomeet deadlines per contract,compliance,andsponsors/CRO/monitors requests
• •Carries out daily operations thatcontribute to the success of Beacon's mission to provide an unparalleled patient experience
• •Performs Medical Assistant duties as needed, including, rooming patients and preparing them for study visits, obtaining and documenting vital signs, height, weight, and medical history updates, assisting providers with exams and procedures per protocol and clinic standards, performing phlebotomy, specimen collection, processing, storage, and shipment per protocol requirements, administering medications and/or injections as delegated and permitted by scope and protocol
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