Clinical Studies Coordinator II, Maya Angelou Center for Health Equity
Job description
JOB SUMMARY
Under departmental direction, the Clinical Studies Coordinator assists with the coordination of community outreach, recruitment, enrollment, and follow-up activities of Alzheimer’s disease research studies. The clinical research coordinator will report to the Principal Investigator and Program Manager. She/He works closely with project staff and staff at collaborating sites to recruit African Americans for Alzheimer's disease (AD) genetics studies. The position is trained and provides overall administrative direction and coordination of policies, procedures, and programs related to AD. She/He will be required to travel and visit participants in their places of residence to assess individuals for inclusion and enrollment in the AD study. Participant visits include consenting study participants, collecting blood samples, administering cognitive assessments, and collecting family and medical history. The Coordinator is responsible for preserving and shipping blood to the Coordinating Site. The Coordinator participates in adjudication meetings for participant clinical classification. The clinical research coordinator assists with Institutional Review Board submissions, communication, and implementation of projects, policies, compliance, and other regulatory issues. The Position requires the use of good judgment and discretion in performing the assigned duties and responsibilities. This position may require the clinical research coordinator to occasionally work non-traditional hours.
EDUCATION/EXPERIENCE
At least a Bachelor's degree in Public Health, Basic Science, or a relevant clinical discipline, but a Master’s degree is preferred. One year of clinical and or survey research experience including interviewing and supervision of data collection procedures is preferred. An equivalent combination of education and experience will be considered. Phlebotomy certification preferred.
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.
- Phlebotomy licensure is preferred.
SKILLS/QUALIFICATIONS
- Excellent interpersonal, oral, and written communication skills
- Excellent reading comprehension
- Strong organizational skills
- Knowledge of computerized data processing
- Flexibility to adapt to changes in daily routine
- Ability to engage intergenerational study participants and family members
- EPIC/WakeOne proficiency to include appropriate documentation of research notes
- Proficient in the use of OnCore/WISER Clinical Trial Management System
- Basic computer skills and knowledge of Microsoft Products
- Fosters/promotes a positive image and professional appearance
- Sensitivity to intercultural relations
- Sensitivity to the maintenance of confidentiality
ESSENTIAL FUNCTIONS
- Works under the direction of the Study Investigators or Program Manager with minimal supervision.
- Plays an active role in the recruitment of patients to study. Represents the project by serving as the study liaison and representative.
- Performs protocol-specific duties required per the research protocol. Assists in the administration and coordination of all phases of the assigned project as directed.
- Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
- Coordinates and participates in recruitment data collection and follow-up activities.
- Collect blood samples.
- 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 promptly.
- 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 ongoing basis.
- May mentor new and less experienced staff.
- Initiate introductory visits following timeliness guidelines per study standards. Actively participates in outreach/community education and/or early detection/screening events around AD.
- Provide presentations around AD and other related dementias.
- Follows established Wake Forest Baptist 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.
WORK ENVIRONMENT
- Clean, comfortable, office environment
- Must be able to travel to collaborating institutions and travel to the homes of the participants
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