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Research Professionals Resources: Training and Certification
A guide for staff who work as research assistants, study coordinators, clinical research coordinators.
Created by Health Science Librarians
Required Trainings
- CITI/Human Subjects TrainingRequired by anyone involved in human subjects research; 3 levels – Biomedical, Social/Behavioral and Data or Specimens Only. Informed consent is incorporated in this training
- Required GCP Training for All UNC Clinical Research StaffEffective October 1, 2014, all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects AND a drug, device, or biologic are expected to document completion of GCP training. The completion of the initial training is effective for 2 years. At the end of a 2 year period, a GCP refresher course will be required
- Clinical Research Management System (CRMS)Required for use submitting CDA’s and CTA’s (confidentiality disclosure agreement (CDA), clinical trial agreement (CTA)
- EPICMandatory if accessing medical records. Required to obtain LMS (Learning Management System) account from the UNC Health Care System
- EHS Training for CTRCMandatory if using CTRC to see subjects
- HIPAAMandatory if accessing private health information for research. Also mandatory to be able to access EPIC
Additional Training
- New Coordinator OrientationThis workshop is strongly recommended for all clinical research coordinators (CRC’s) , research assistants, or research administrators who are new to the research role or new to working at UNC
- CTRC (Clinical & Translational Research Center)This is new user and orientation training and houses links to additional training that may be useful
- Department of Environment, Health and Safety (EHS)This is particularly useful if seeing research subjects in a healthcare clinic setting. See "Self Study units" to complete required trainings.
- Training Elements of Human Subjects Research Coordination - CTSA Research Coordinators TaskforceThis is a list of categories of content to cover when training coordinators, from regulatory topics to job-specific and institution specific topics. It is the result of a research project Claudia G. Christy (NC TraCS institute) and Nancy Needler (U Rochester) led together with the help of a national subcommittee of the NIH CSTA Consortium.
Phlebotomy
- Phlebotomy Training for Clinical Research Staff (From NRP)This 3 session course covers: a) the process for safely completing venipuncture; b) the supplies needed to successfully complete venipuncture; and c) prevention and management of potential complications occurring when performing venipuncture.
Gale's World of Health states: "Phlebotomy is the act of drawing or removing blood from the circulatory system through a cut (incision) or puncture in order to obtain a sample for analysis and diagnosis. Phlebotomy is also done as part of the patient's treatment for certain blood disorders."
Medical Laboratory Observer is a lab professionals journal with regular features on phlebotomy and training needs. CINAHL+ has full-text from September 2001 to present here.
Certification Programs & Continuing Ed (Non-UNC)
- ACRP Certification ProgramBe certified as a CRA, CRC, or PI with the Association of Clinical Research Professionals certification program.
- CCRA, CCRC, CPI certification through ACRPThe Association of Clinical Research Professionals offers these certifications: Clinical Research Associate (CCRA), Clinical Research Coordinator (CCRC), and Principal Investigator (CPI).
- Duke Clinical Research Institute (DCRI) - Education/TrainingDCRI offers continuing ed and training opportunities.
- FDA - News & Educational Resources for Health ProfessionalsA hub of resources for clinical research and health professionals from the FDA.
- Social Science Research Institute @ Duke - Education & TrainingResources on social sciences research design, ethics, data collection, and statistical and data analysis.
- Society for Clinical Research Associates (SoCRA) Certification ProgramA non-profit "committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities."
- The Institute for Clinical Research (ICR)An international professional group for clinical researchers. They offer training on all aspects of clinical research.
- Regulatory Affairs Professionals Society (RAPS)A global organization for professionals "involved with the regulation of healthcare and related products." RAPS offers educational resources and activities on topics that reflect your scope of practice in live and virtual forums.
Webinars
- Association of Clinical Research Professionals - WebinarsShort, instructor-led, interactive, live online sessions on regulatory developments and industry trends.
- The Odum Institute at UNC - Video coursesWebinars on research and data.
- TraCS Institute - Webinars & Training on RecruitmentWebinars and presentations about recruiting for clinical trials.