CLINICAL RESEARCH ASSOCIATE

UNC Rex Healthcare - Raleigh, NC (30+ days ago)4.4


CLINICAL RESEARCH ASSOCIATE - CANCER RESEARCH-PRO001WO
Description
The essential duties and responsibilities of a Clinical Research Associate for the Cancer Research Department include:
  • Maintaining an environment of safety for patients, self and others
  • EnsuringIRB approval has been received prior to the study initiation
  • Participating in on site-initiation visits, start-up meetings, Site Monitoring Visits (SMVs) with sponsors and CROs and attending SMVs for assigned studies
  • Recruitingstudy subjects for the UNC Tissue Procurement studies and additional studies
  • Trackingrecruitment daily and coordinating subject participation
  • Screeningparticipants for research studies as authorized by the IRB via a Limited Waiver of HIPAA
  • Maintaining a master subject screening log for the department
  • Obtainingwritten informed consent and HIPAA authorization under the supervision of the study's Team Lead (either an Oncology Research Nurse or Clinical Research Specialist)
  • Collecting and entering subjectdata on case report forms and in the electronic data capture (EDC) systems according to sponsor requirements or within 5 business days of visit
  • Assistingwith subject data collection in ancillary studies such as Quality of Life, Health Utilization or Patient Reported Outcomes
  • Anticipating and managingstudy required data collection timepoints and biospecimen collections for each subject using trackable methods such as an Excel spreadsheet, Outlook or EDC calendar
  • Ensuringaccuracy and completeness of data according to Good Clinical Practice Standards
  • Participatingin compliance audits (regulatory inspections) of site records to include data and source document review
  • Anticipatinglaboratory department needs for sample kit preparation including tube labeling, processing instructions and final disposition (overnight or batch shipment), entering specimens into the sponsor's specimen tracking system and maintaining the Oncology Research Department's biospecimen log daily
  • Contributingto quality assurance projects in the Oncology Research program including annual and study specific accrual rates, biospecimen collection accuracy and major/minor deviation tracking
  • Contributingto operational projects for the department including IND safety reporting, pharmacy binder management and off site storage of closed studies
  • Collaboratingwith Peri-Operative Services, Anesthesia Pre-Care and Rex Histopathology personnel
  • Assistingresearch personnel in identifying clinical trial options for our providers within the UNC Rex system and outside of the system
  • Addressing data queries in a timely manner
  • MaintainingGood Clinical Practice Standards
Other duties may be assigned.
Qualifications
Requirements
Candidate is required to have a Bachelor's Degree in a health related field,Human Subjects Protection Training, Good Clinical Practice Training, Dangerous Goods Shippers Training and have or be able to obtain a Certified Clinical Research Professionals (CCRP) or Certified Clinical Research Associate (CCRA) certification within two (2) years of hire. It is preferred that the candidate have clinical research experience.
Primary Location
United States-North Carolina-Raleigh
Department
REXH-15040-Cancer Research
Shift
Day Job