Clinical Studies Coordinator II, Gerontology
Winston-Salem, NC, United States
Job ID: 143550
Job Family: Research Services
Status: Full Time
Shift: Day
Job Type: Regular
Department Name: 55811085033664-Gerontology
Overview
JOB SUMMARY
Under departmental direction and in coordination with the Principal Investigator, the CSCII maintains various aspects of the iGROOVE study including oversight of participant recruitment and enrollment, regulatory monitoring and reporting, conducting study visits according to protocol to collect, compile and submit data, administer participant questionnaires, and oversight of other team members to manage day to day workflow. Ability to manage the workload of a study with increased complexity.
EDUCATION/EXPERIENCE
Bachelor's degree with two years’ experience in clinical research; or an equivalent combination of experience and education.
LICENSURE, CERTIFICATION, and/or REGISTRATION
- SOCRA or ACRP Certification preferred.
- Must complete the CITI certification for Human Subject Research if not already completed.
- All additional required WakeOne training for research coordinators.
ESSENTIAL FUNCTIONS
- Works under the direction of the Study Investigators or departmental Manager with minimal supervision.
- Plays an active role in recruitment of patients to study.
- Performs protocol specific duties required per the research protocol.
- Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
- Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol.
- Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents.
- Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
- Provides staff relief as required to meet the needs of the department. Participates in scheduled team/department meetings. Participates in quality improvement projects on an on-going basis.
- May mentor new and less experienced staff.
- Follows established institutional and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
- Performs other related duties as assigned or requested.
SKILLS/QUALIFICATIONS
- Excellent interpersonal, oral, and written communication skills
- Excellent reading comprehension
- Strong organizational skills
- EPIC/WakeOne proficiency to include appropriate documentation of research notes
- Proficient in the use of OnCore/WISER Clinical Trial Management System
- Basic computer skills
- Fosters/promotes a positive image and professional appearance
- Sensitivity to intercultural relations
- Sensitivity to the maintenance of confidentiality
- Knowledge of Microsoft Products
WORK ENVIRONMENT
Clean, comfortable, office environment