Clinical Studies Coordinator I, Comprehensive Cancer Center
3 weeks ago
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 Administrative 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:
- Bachelor's degree in a related field of study or an equivalent combination of experience and education
- Experience in a medical and/or research setting
Additional Desirable Qualifications:
- Paramedical or other clinical experience
Reports To: Administrative Director of Clinical Protocol and Data Management, Comprehensive Cancer Center
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:
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:
- Knowledge of medical terminology.
- Exposure to clinical trials or related health field is preferred.
- Excellent oral/written communication and organizational skills.
- Excellent reading comprehension.
- Foster/promote a positive image and professional appearance.
- Sensitivity to intercultural relations.
- Sensitivity to the maintenance of confidentiality.
- Ability to use Microsoft products, access data in computer data bases, compile data, and research information.
- Proofread documents.
- Troubleshoot problems.
About Us
Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.
Atrium Health is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem - that includes Brenner Children's Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians.
Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing - for all.
It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process. Thanks in advance for your flexibility.
About the Team
Mission, Vision and Culture Commitments
Mission
To improve health, elevate hope and advance healing - for all.
Vision
To be the first and best choice for care.
Culture Commitments
We create a space where all Belong
We Work as One to make great things happen
We earn Trust in all we do
We Innovate to better the now and create the future
We drive for Excellence - always
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Winston-Salem, North Carolina, United States Atrium Health Full timeOverview 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 Administrative Director of Clinical Protocol and Data Management, the Clinical Studies Coordinator I coordinates activities to support...
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Winston Salem, United States Atrium Health Full timeOverview 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....
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