Clinical Studies Coordinator I, Comprehensive Cancer Center

Overview

Job Summary: 

Under the direction of the Study Investigators and Disease Group Chair, mentorship of experienced clinical studies coordinator staff, supervision of the Nurse Team Leader and the leadership of the Director of Clinical Protocol and Data Management, the Clinical Studies Coordinator I coordinates activities to support research studies. Able to manage low complexity trials after completion of orientation. Assignments are gradually adjusted to add increased responsibility based on demonstrated competency. Mentored by an experienced clinical research coordinator II or III, serves as the principle administrative liaison for assigned studies. Follows and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires, and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor.

Education/Experience: 

Minimum Acceptable Qualifications:

1. Bachelor's degree in a related field of study or an equivalent combination of experience and education 
2. Experience in a medical and/or research setting

Additional Desirable Qualifications:

1. Paramedical experience

Licensure, Certification and/or Registration: 

1. SOCRA or ACRP certification preferred
2. Must complete the CITI certification for Human Subject Research if not already completed
3. All additional required WakeOne training for research coordinators

Essential Functions:

Study Conduct

• Works under the supervision of the Study Investigators, Disease Group Chair and the direction of the Administrative Director of Clinical Protocol and Data Management.  
• Works in conjunction with a clinical studies coordinator mentor and the oversight of a Nurse Team Leader to gradually assume more responsibility and workload
• Assists in the recruitment of patients to study by helping to identify potential eligible patients who are scheduled to be seen in the clinic and communicating the information to the Study Team.
• Performs protocol specific duties required per the research protocol, including but not limited to:
  • Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
  • Confirms and documents subject eligibility.
  • As part of the team, ensures all protocol procedures are ordered and completed as specified in the protocol.
  • Randomizes subjects using interactive voice response systems or other systems as applicable.
  • Administers standardized tools or questionnaires, such as Quality of Life assessments, if appropriately credentialed.
  • Assembles lab kits and other supplies in preparation to obtain required biospecimen samples and transports to appropriate laboratories for processing; ships samples externally per International Air Transport Association (IATA) requirements.
  • Optimizes the safety of research subjects by monitoring and reporting any adverse events to the investigators and other members of the study team.
  • Participates in required teleconferences, on site meetings and off site investigator meetings, as required.

Regulatory Compliance and Documentation.

• Fulfills sponsor requirements related to reportable information, including: adverse events, unanticipated problems, other information required by the sponsor protocol.

Data Management

• 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.

Personnel Management

• 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.

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 and Qualifications:

1. Knowledge of medical terminology.
2. Exposure to clinical trials or related health field is preferred.
3. Excellent oral/written communication and organizational skills.
4. Excellent reading comprehension.
5. Foster/promote a positive image and professional appearance.
6. Sensitivity to intercultural relations.
7. Sensitivity to the maintenance of confidentiality.
8. Ability to use Microsoft products, access data in computer data bases, compile data, and research information.
9. Proofread documents.
10. Troubleshoot problems.