Clinical Studies Coordinator II Alzheimer’s Disease Research Center

Atrium Health; Winston-Salem (NC); In loco; USD 65.000 - 85.000; Tempo pieno

Descrizione del lavoro

Wake Forest Baptist is hiring a Clinical Studies Coordinator II to independently coordinate clinical research studies within the Alzheimer's Disease Research Center. You will manage data, consent processes, and regulatory compliance while collaborating with interdisciplinary teams.

The role requires a Bachelor's degree with two years of clinical research experience; SOCRA/ACRP certification preferred and CITI training on human subjects.

Competenze

• Bachelor's degree with two years' experience in clinical research, or an equivalent combination of experience and education.
• SOCRA or ACRP Certification preferred; complete CITI Human Subjects Research training if not already done.
• Wake Forest Baptist research training (WakeOne) and related guidelines to be followed.

Mansioni

• Coordinate and execute multiple clinical studies with minimal supervision.
• Assist in patient recruitment and obtain informed consent when applicable.
• Abstract data from medical records and complete case report forms accurately.
• Report adverse events and unanticipated problems as required by sponsor protocol.
• Maintain source documents and communicate data management issues promptly.
• Participate in team meetings and quality improvement activities; mentor staff as needed.

Conoscenze

Interpersonal communication

Written communication

Reading comprehension

Organization skills

Confidentiality

Intercultural sensitivity

Formazione

Bachelor's degree in clinical research

Strumenti

EPIC/WakeOne

OnCore/WISER

Microsoft Office

Descrizione del lavoro

***Onsite Position***

The Clinical Studies Coordinator II (CSC II) independently coordinates and executes multiple clinical research studies of moderate to high complexity within the Alzheimer's Disease Research Center, operating with minimal managerial oversight. This role requires strong organizational and problem-solving skills, the ability to prioritize competing responsibilities, and a high level of accountability for participant safety, data integrity, and regulatory compliance. The CSC II demonstrates professional comportment in all interactions, including clear, respectful, and empathetic communication with research participants—particularly those who may be cognitively impaired—as well as effective collaboration with interdisciplinary teams. This position requires the ability to work autonomously, exercise sound judgment, and consistently deliver high-quality work in a fast-paced clinical research environment.

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 Clinical Research Nurse 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 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.

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