CLINICAL TRIALS COORDINATOR I-DCRI - Site Support & Management
CLINICAL TRIALS COORDINATOR I-DCRI - Site Support & Management
DCRI - Site Support & Management
Occupational Summary:The Clinical Operations Trial Coordinator (CTC) is responsible for performing and implementing a variety of independent duties involved in the organization, training,oversight, documentation,conduct and clinical data review for clinical trials that are being managed by Duke Clinical Research Institute (DCRI). This work is done for phaseI, II, III, IV, trials and other clinical research endeavors conducted by DCRI. .
Responsibilities: Project/Trial Organization• Draft/Create ProjectSpecific Plans/Documents for trial activities:Feasibility Form CTMS Setup Form Data Entry Guidelines (DEGs) Manual of Operations (MOO/MOP) Inservice Manual Remote Monitoring Plan Regulatory document collection process Custom Reports
• Compile and review site feasibility information and provide site recommendations/feedback totrial supervisor
• Provide content to Clinical Monitoring Plan (CMP).
• Maintain Remote Monitoring Plan and make changes as needed.Project/Trial Training
• Create and deliver trainings for ProjectSpecific Plans/Documents by utilizing a variety of applications (Word, Excel, PowerPoint)
• Provide trial training and guidance to research staff (internal and external) for conducting the study in accordance with the following: Protocol SOPs Trial specific procedures Applicable regulations Site Management Oversight
• Serve as trial supervisor, mentor and coach for all assigned Clinical Trials Associates(CTAs) and provide input into all assigned CTAs evaluations
• Routinely review available metrics reports, data entry and inspect study files to ensure completeness and accuracy. Take action as appropriate by providing feedback/training if required
• Oversee and ensure distribution of appropriate forms, supplies,equipment, laboratory samples,and investigational product are received by the site according to the established trial timeline
• Communicate with laboratories or investigators regarding laboratory findings
• Direct the process for collection, labeling, storage, or shipment of specimens
• Prepare for or participate in quality assurance audits conducted by study sponsors,federal agencies Project/Trial Documentation
• Serve as Clinical Trial Management System (CTMS) user expert (SuperUser) by being able to perform, explain and train on the following activities:
DEG Clinical Trial Management System Request Form (CTMSR) Site Creation Global Data Requests Site Status Activity Plans Milestone Tracking Document attachment (Training/Safety Letters/other) Account Affiliations Conversation Log Available reports Confirmation/FollowUp Letters• Oversee and review CTA CTMS data entry and Trial Master File (TMF)filing is in compliance with DEG and Standard Operating Procedures (SOPs)• Supervise the CTA review of the following regulatory documents: Protocol Signature Page Form FDA 1572 Principal Investigator Curriculum Vitae (CV) and Medical License Principal Investigator Financial Disclosure Subinvestigator Curriculum Vitae (CV) and Medical License Subinvestigator(s) Financial Disclosure(s) IRB Approval of Protocol and any Amendment(s) IRB Approval of Informed Consent Form IRB Approval of Assent Form IRB Approval of Translation of ICF & Assent Form Authorization Investigator's Brochure (IB) IRB Membership Roster or FWA number Clinical Trial Conduct• Interpret protocols and advise research staff (internal and external) on appropriate conduct of the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations• Identify protocol problems, inform trial supervisor of problems, or assist in problem resolution efforts such as protocol revisions• Monitor all trial activities/communications to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.• Identify action items and discuss with appropriate research staff.Communicate routine and unusual findings to trial supervisor• Regularly review trial and site status information and enter updates into required systems to maintain accurate, current reports.• Confer with site coordinators and physicians to explain protocol an delicit compliance with regulations; ensure compliance with Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.• Follow established guidelines in the collection of clinical data and/or administration of clinical trials Clinical Data Review• Perform inhouse monitoring activities by independently reviewing and evaluating the following: Informed Consent Forms (ICFs) Source documentation Case Report Forms (CRFs) Adverse Events (AEs) Serious Adverse Events (SAEs) Laboratory results• Uses knowledge of protocol to interpret data and work with other functional groups to resolve clinical data issues• Routinely use data management reports/system to identify/resolve discrepancies in the clinical data
1941 CLINICAL TRIALS COORDINATOR I
Job Family Level
Full Time / Part Time
Regular / Temporary
Work requires graduation from an accredited degree program providingclinical training as a Registered Nurse (RN). Physician's Assistant(PA) or Pharmacists plus one year healthcare experience, or one of thefollowing equivalents:1. Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, Licensed Practical Nurse) or Associates degree inClinical Trials Research related curriculum plus a minimum ofthree years healthcare experience; or2. Completion of a Master's degree in Public Health, HealthAdministration or a related area with no additional experience; or3. Completion of a Bachelor's degree plus a minimum of one yeardirectly related clinical trials research; or4. Completion of a Bachelor's degree plus a minimum of two yearsclosely related research experience.**State of North Carolina licensure may be required**
None required beyond that described above.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
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Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.