With guidance and training, is responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. Manages screening, implements recruitment procedures, consenting, enrollment, randomization and study conduct from planning through study closeout. Performs or implements processes to assure study-related procedures are performed as required and objectives and timelines are met. Maintains accurate and timely documentation and communication with Investigators, participants, IRB, sponsors and other research related entities.
â¢Exhibits the capability to understand and follow a clinical/translational study protocol, obtaining training and seeking assistance when needed, to safely and accurately perform or assess required protocol procedures. Uses coordination skills and works collaboratively with study participants, other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures,completingrequiredparticipantregistrationinStarPanel,conductinginterviewsandlaboratoryanddiagnostic studies,trackingmedicationusageandotherprotocolspecificinvestigationalprocedures
â¢Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/orthesponsorpriorto,duringandaftertheconductofaclinical/translational trial.Participatesinperiodicsitevisits fromsponsor,regulatoryauthoritiesandotherstoreviewresearch,sourcedocumentationandresearchprocedures
â¢Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic)withawarenessandattentiontotherequirementsforaccuracy,completenessandtimeliness.Attendstoquery resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policiesandgoodclinicalpractice
â¢Familiar with the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion,monitors,detectsandreportsadverseeventsmeetingrequirementsofregulatorybodies.Coordinatesactivities andgathersinformationfromavarietyofsourcestoachievestatedoutcomes
â¢With direction assists with study completion, study closeout and archiving of study files, ensuring completeness and continuityofallstudydata,performingongoingchecksofclinical/translational datathathasbeenenteredonthecase reportforms(paperorelectronic)orinreports
â¢Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsiblefor,orconcernedabout,protectionsforhumanparticipantsofresearchandthroughongoingmonitoringof trial processes andparticipants
â¢With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriatesubjectsareenrolledinclinical/translationaltrialsandremaineligibleforcontinuedparticipation.Engagesin openandpositivecommunicationwithstudyparticipantsandcoworkers
â¢Participatesintheongoinginformedconsentprocess,ensuringthathumansubjects,theirfamilies,andotherhealthcare providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial
â¢Encouragesopencommunicationwithparticipantsbyprovidingthemwithcontactinformationandbeingavailableto answer, address or refer theircalls
â¢With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocoltothePrincipalInvestigatorand/orseniorpersonnelwhowilldetermineifaprotocolamendmentorothersafety reportingtoappropriatefunding/regulatoryagenciesisrequired
â¢Utilizes or obtains knowledge of disease processes to observe for and report adverse events in a timely and accurate mannertotheprincipalinvestigatorandallregulatoryauthorities(IRB,Sponsor,FDA,NIH,etc.)asrequiredbyprotocol, policies and procedures andregulations
â¢Actively identifies and participates in training, education, and development activities to improve own knowledge and performancetosustainandenhanceprofessionaldevelopment.Pursuesavenuestocontinueeducation(i.e.,in-services, seminars,etc.)
â¢Frequent:Noise:Mayincludeexposuretooccupationalnoiselevelswhichequalorexceedan8-hrtime-weightedaverage of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodicaudiometry.
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