School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nationâ€™s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
The Government Trials & Network 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 phase I, II, III, IV, trials and other clinical research endeavors conducted by DCRI.
Most DCRI positions can be done remotely for candidates who live in the following states: NC, CA, FL, GA, MD, NY, SC, TN, TX, VA, and District of Columbia (DC), Arizona, Hawaii, Illinois, Montana.
Primary Responsibilities and Tasks:
1. Project/Trial Organization
Compile and review site feasibility information and provide site recommendations/feedback to trial supervisorProvide content to Clinical Monitoring Plan (CMP).Maintain Remote Monitoring Plan and make changes as needed.
- Draft/Create Project‐Specific Plans/Documents for trial activities:
- Feasibility Form
- CTMS Setup Form
- Data Entry Guidelines (DEGs)
- Manual of Operations (MOO/MOP)
- In‐service Manual
- Remote Monitoring Plan
- Regulatory document collection process
- Custom Reports
2. Project/Trial Training
- Create and deliver trainings for Project‐Specific 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:
- Trial specific procedures
- Applicable regulations
3. 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
4. Project/Trial Documentation
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 PageForm FDA 1572Principal Investigator Curriculum Vitae (CV) and Medical LicensePrincipal Investigator Financial DisclosureSub‐investigator Curriculum Vitae (CV) and Medical LicenseSub‐investigator(s) Financial Disclosure(s)IRB Approval of Protocol and any Amendment(s)IRB Approval of Informed Consent FormIRB Approval of Assent FormIRB Approval of Translation of ICF & Assent FormIRB Approval of Health Insurance Portability and Accountability Act (HIPAA)Investigator’s Brochure (IB) IRB Membership Roster or FWA number
- Serve as Clinical Trial Management System (CTMS) user expert (Super User) by being able to perform, explain and train on the following activities:
- 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/Follow‐Up Letters
5. 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.
• Follow established guidelines in the collection of clinical data and/or administration of clinical trials
• Confer with site coordinators and physicians to explain protocol and elicit compliance with regulations; ensure compliance with Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
6. Clinical Data Review
Uses knowledge of protocol to interpret data and work with other functional groups to resolve clinical data issuesRoutinely use data management reports/system to identify/resolve discrepancies in the clinical data
- Perform in‐house 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
- Identifies and follows through on opportunities for self-improvement.
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician’s Assistant (PA) or Pharmacist plus one year of healthcare experience, or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) plus a minimum of three years healthcare experience; or
2. Completion of a master’s degree in Public Health, Health Administration or a related area with no additional experience; or
3. Completion of a bachelor’s degree plus a minimum of one year directly related experience in clinical trials research; or
4. Completion of a bachelor’s degree plus a minimum of two years closely related research experience.
**State of North Carolina license may be required. ** EXPERIENCE
None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, 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 robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.