Clinical Studies Coordinator II, Infectious Disease
3 weeks ago
Overview
The primary focus of the Atrium Health Wake Forest Baptist Infectious Disease Clinical Trials Unit is on ambulatory studies involving HIV/AIDS, viral hepatitis, and other infectious diseases including COVID-19. Occasional evening and weekend work may be required as job duties demand.
JOB SUMMARY
Under departmental direction, coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops 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
- Bachelor's degree in a related field of study with two years' experience in clinical research; or an equivalent combination of experience and education.
- Experience in public health and/or infectious diseases research desired.
- Experience with HIV, sexually transmitted infections, sexual health, and/or oncology care preferred.
- Experience with Electronic Medical Record systems and/or Clinical Trial Management systems.
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 certification preferred.
ESSENTIAL FUNCTIONS
- Work under the direction of the Study Investigators and Project Manager with minimal supervision.
- Read assigned protocols and associated study materials to ensure an understanding of how each study is to be conducted. Conduct each study as described in the protocol.
- Responsible for recruiting patients for clinical studies. Track the sources of patient referrals which include referring physicians, Medical Center laboratories, and other sources. Screen potential subjects for eligibility. Schedule subjects for study visits.
- Perform technical procedures (vital signs, EKG’s, blood draws, urine pregnancy tests, etc.) on clinical subjects under the direction of the principal investigator or his/her designee(s). Process biologic specimens (blood, urine, tissue samples) for appropriate shipping and storage. Order labs/procedures to be performed by NCBH Pathology.
- Perform all aspects of the data collection, reporting, auditing, and querying process for clinical trials. This may include the development of data collection forms. Assist with organizing the files for long-term archiving.
- Maintain appropriate study subject records (source documents) as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study by obtaining and interpreting pertinent data from electronic and paper medical records.
- Perform day-to-day administrative and clerical duties such as regulatory document submission, IRB updating, adverse event reports, etc.
- Consult and cooperate with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study.
- Perform other related duties incidental to the work such as attending Investigator Meetings, preparing for monitoring visits, etc.
- Serve as a back-up coordinator for studies in case of primary coordinator’s absence. Assist other coordinators as needed.
- Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
- Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
- 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 Atrium Health 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.
SKILLS/QUALIFICATIONS
- Excellent interpersonal, oral, and written communication skills
- Excellent reading comprehension
- Strong organizational skills, attention to detail, ability to troubleshoot and solve problems
- Understanding of medical and/or scientific terminology.
- EPIC/WakeOne proficiency to include appropriate documentation of research notes
- Proficient in the use of OnCore/WISER Clinical Trial Management System
- Ability to manage multiple projects simultaneously with various priorities and deadlines
- 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
-
Winston-Salem, North Carolina, United States Atrium Health Full timeOverview The primary focus of the Atrium Health Wake Forest Baptist Infectious Disease Clinical Trials Unit is on ambulatory studies involving HIV/AIDS, viral hepatitis, and other infectious diseases including COVID-19. Occasional evening and weekend work may be required as job duties demand.JOB SUMMARYUnder departmental direction, coordinates activities to...
-
Winston-Salem, North Carolina, United States Atrium Health Full timeOverview This vital role aims to facilitate and support the expansive research portfolio of the Infectious Disease section, which includes but is not limited to Microbial Ecology and Emerging Diseases, Military Applied Research, Sexually Transmitted Infections, Complex Infections Associated with Addiction, and Vaccine and Therapeutics development.Working...
-
Winston Salem, United States Atrium Health Full timeOverview This vital role aims to facilitate and support the expansive research portfolio of the Infectious Disease section, which includes but is not limited to Microbial Ecology and Emerging Diseases, Military Applied Research, Sexually Transmitted Infections, Complex Infections Associated with Addiction, and Vaccine and Therapeutics development. Working...
-
Winston-Salem, North Carolina, United States Atrium Health Full timeOverview JOB SUMMARYUnder departmental direction, the clinical studies coordinator II coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping systems...
-
Clinical Studies Coordinator II, Gerontology
3 weeks ago
Winston-Salem, North Carolina, United States Atrium Health Full timeOverview JOB SUMMARYUnder departmental direction, the Clinical Studies Coordinator II coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping systems...
-
Winston Salem, United States Atrium Health Full timeOverview JOB SUMMARY Under departmental direction, the clinical studies coordinator II coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping...
-
Clinical Studies Coordinator II, Gerontology
1 week ago
Winston-Salem, United States Wake Forest University School of Medicine Full timeJob DescriptionJOB SUMMARYUnder departmental direction, the Clinical Studies Coordinator II coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping...
-
Clinical Studies Coordinator II, Gastroenterology
19 hours ago
Winston Salem, NC, United States Atrium Health Full timeOverview JOB SUMMARY Under departmental direction, the clinical studies coordinator II coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping...
-
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...
-
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 Administrative Director of Clinical Protocol and Data Management, the Clinical Studies Coordinator I coordinates activities to support...
-
Winston-Salem, North Carolina, United States Atrium Health Full timeOverview JOB SUMMARYUnder 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...
-
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....
-
Clinical Studies RN II, Surgery Trauma
2 weeks ago
Winston Salem, United States Atrium Health Full timeOverview JOB SUMMARY Provides specialized nursing care/treatment to a specific group of patients who are participating in clinical research studies within the Surgery/Trauma department of Atrium Health Wake Forest Baptist. Functions as part of a research team that may consist of Investigators, Clinical Studies Coordinators, Data Managers, Regulatory...
-
Clinical Studies RN II, Surgery Trauma
2 weeks ago
Winston-Salem, North Carolina, United States Atrium Health Full timeOverview JOB SUMMARYProvides specialized nursing care/treatment to a specific group of patients who are participating in clinical research studies within the Surgery/Trauma department of Atrium Health Wake Forest Baptist. Functions as part of a research team that may consist of Investigators, Clinical Studies Coordinators, Data Managers, Regulatory...
-
Infectious Disease Physician
4 days ago
Salem, United States FCS, Inc. Full timeInfectious Disease Physician needed full-time for a multi-specialty group practice comprised of nearly 200 physicians, nurse practitioners and healthcare professionals. Candidate will join 2 established Infectious Disease Physicians providing in-patient consults with outpatient clinic responsibilities. The population is varied. Become a member of the Mass...
-
Winston-Salem, United States Wake Forest University School of Medicine Full timeJob DescriptionJob 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...
-
Winston-Salem, United States Wake Forest University School of Medicine Full timeJob DescriptionJOB SUMMARYUnder 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....
-
Infectious Disease Physician
2 days ago
Salem, MA, United States FCS, Inc. Full timeInfectious Disease Physician needed full-time for a multi-specialty group practice comprised of nearly 200 physicians, nurse practitioners and healthcare professionals. Candidate will join 2 established Infectious Disease Physicians providing in-patient consults with outpatient clinic responsibilities. The population is varied. Become a member of the Mass...
-
Senior Clinical Research Coordinator
4 days ago
Winston Salem, United States ICON Clinical Research Full timeAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...
-
Physician - Infectious Diseases
3 days ago
Salem, United States Barton Associates Full timeYour next locum tenens opportunity awaits in Oregon! Our client is looking for a physician specializing in infectious diseases to begin coverage immediately. Hours include 8 hour shifts or 24 hour call coverage shifts. The selected locum will be handling rounds, consults, UTIs, cellulitis, and other infectious disease cases. This facility uses Epic. Reach...
