CLINICAL RESEARCH COORDINATOR
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary< p>Provideleadership and coordination in the conduct of multiple, c omplex oncologyclinical trials and research studies including Investigat ional Products [IP]for the Duke Cancer Institute’s [DCI] GI Clinical Res earch Program [GI].The Oncology Clinical Research Unit [C RU]oversees the conduct of research.
Oper ations, Study and Site Management – 40% Effort
Employstrategies to maintain recruitment and retention rates, and assist participantswith individual needs.Collectinformati onto determine appropriate study feasibility, recruitment andretention strategies.Evaluate processesto identify issues related t o recruitment and retention rates; offersolutions.
Workclosely with the Principal Investigator [PI] andstudy team to recruit, screenand enroll participants for studies. Conduct and document consent for studyparticipants. Schedule participants andconduct visits for studies; conduct and docu ment visits.
Coordinatestudy ac tivities with teammates and colleagues to successfully implement andcond uct the study.Recognize and offersolutions to study probl ems. Escalate issues appropriately.Take part in site initiation and closeoutvisits.Assist in the development of ne wstudies.
Maintainstudy's compliance with inst itutional requirements and policies.Maintain appropriate study-leveldocumentation including regulatory binders, enrollment logs, and patientregistration in the system of record. Record ad verse events [AE] and report promptly.Oversee maintenance of Delegation ofAuthority Logs and training of key personnel on study s pecific duties.
Assistwith the development of Conflict of Interest [COI], Data Safety M onitoringPlans [DSMPs], and Research Data Security Plans [RDSPs].Assist with the coordination of externalmonitoring boards.
Followprocedures and documentation of study paymen t and participant care expenses ina timely fashion.Monito r financialstudy milestones and report appropriately. Coord inate with financial teams and participate in budget development.Assist with study budgets and closeouts. p>
Communication – 20% Effort< p>Serveas primary liaison with sponsors, study personnel and PI fo r assignedstudies.Collaborate, and communicatewith other study personnel as required. Communicate concerns clearly i n a professional manner.Respond timely to emails, phone c alls andquestions.Refer more complex questions andescalat e issues to others as appropriate.
Data – 20% Effort
UseElectronic D ata Capture [EDC] systems and enter data accurately.Detec t issues related to data capture,collection or management and suggest so lutions.
Complywith required pro cesses, policies, and systems to ensure data security andprovenance.Recognize and reportvulnerabilities related to security of ph ysical and electronic data.Assist in investigatingincomp lete,inaccurate or missing data and documents to ensure accuracy and com pleteness ofdata.
Leadershi p – 10% Effort
Activelynetwork. span>Provide leadership within theteam.Actively and proac tivelyparticipate in team meetings, committees, task forces and ad hoc g roups.
Encouragecareer developm ent by actively seeking out continuing educationopportunities. span>Participate in scientificpresentations and publications.
Serveas an expert resource for colleagues andteammates.Mentor staff, including those in the same jobtitle.Support colleagues in theirproject work; encoura ge completion.
Ethics – 10% Effort
Communicateto study staff and res earch participants the difference between clinical andresearch activitie s, and the risks and benefits of study participations.Rec ognize when staff and patients are havingdifficulty with the distinction and work hard to help them understand thedifferences.
Summarizeand clarify for study teams, the profes sional guidelines and code of ethicsrelated to the conduct of clinical r esearch.
Knowand follow policies , standard operating procedures [SOPs], regulations andprotocol requirem ents that govern clinical research.Maintain Duke and proj ect specific trainingand certification requirements.
Basic Life Saving [BLS]certification from the American Heart Asso ciation or Duke approved equivalentcourse is a requirement of this posit ion.
Other work asassigned.< span>