Coordinates submissions of human subjects research project to the Institutional Review Board (IRB) andof Investigational New Drug Applications (IND's) to the U.S. Food and Drug Administration (FDA)
Coordinates submissions of human subjects research project to the Institutional Review Board (IRB) andof Investigational New Drug Applications (IND's) to the U.S. Food and Drug Administration (FDA)
Clinical Research Coordinator-Hematology
Columbus, OH · On-site
$23.50 - $31.25/hr
Assists with IRB submissions, modifications and amendments; collaborates with an interdisciplinary research team made up of members from the Division of Hematology, other personnel within the OSUWMC ...
Clinical Research Coordinator-Hematology
Columbus, OH · On-site
$23.50 - $31.25/hr
Assists with IRB submissions, modifications and amendments; collaborates with an interdisciplinary research team made up of members from the Division of Hematology, other personnel within the OSUWMC ...
Clinical Research Coordinator-Hematology
Columbus, OH · On-site
$22 - $29.25/hr
Assists with IRB submissions, modifications and amendments; collaborates with an interdisciplinary research team made up of members from the Division of Hematology, other personnel within the OSUWMC ...
Clinical Research Coordinator-Hematology
Columbus, OH · On-site
$22 - $29.25/hr
Assists with IRB submissions, modifications and amendments; collaborates with an interdisciplinary research team made up of members from the Division of Hematology, other personnel within the OSUWMC ...
Clinical Research Coordinator III (RN) *Sign On Bonus*
Columbus, OH · On-site
$66K - $83K/yr
Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file. * Comply with reporting of safety related ...
New
Clinical Research Coordinator III (RN) *Sign On Bonus*
Columbus, OH · On-site
$66K - $83K/yr
Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file. * Comply with reporting of safety related ...
New
Vice Chair of Research, Psychological Services and Behavioral Health Service Line / Senior Research
Valley View, OH · On-site
Mentor junior scientists, research assistants, and clinical faculty in research design, IRB ... Monday-Friday, 8:00 AM-4:30 PM; occasional evenings/weekends. Must be able to lift/move up to 50 ...
New
Vice Chair of Research, Psychological Services and Behavioral Health Service Line / Senior Research
Valley View, OH · On-site
Mentor junior scientists, research assistants, and clinical faculty in research design, IRB ... Monday-Friday, 8:00 AM-4:30 PM; occasional evenings/weekends. Must be able to lift/move up to 50 ...
New
Clinical Research Coordinator II - RI Rheumatology
Columbus, OH · On-site
$23.50 - $31.25/hr
Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion ...
Clinical Research Coordinator II - RI Rheumatology
Columbus, OH · On-site
$23.50 - $31.25/hr
Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion ...
Certified Research Registered Nurse
Columbus, OH · On-site
$66K - $83K/yr
... Board (IRB) policies and procedures. • A liaison with outside organizations related to research activities. • Develops and leads oncology research activities that meet Mount Carmel Oncology ...
Certified Research Registered Nurse
Columbus, OH · On-site
$66K - $83K/yr
... Board (IRB) policies and procedures. • A liaison with outside organizations related to research activities. • Develops and leads oncology research activities that meet Mount Carmel Oncology ...
Certified Research Registered Nurse
Columbus, OH · On-site
$64K - $80K/yr
... Board (IRB) policies and procedures. • A liaison with outside organizations related to research activities. • Develops and leads oncology research activities that meet Mount Carmel Oncology ...
Certified Research Registered Nurse
Columbus, OH · On-site
$64K - $80K/yr
... Board (IRB) policies and procedures. • A liaison with outside organizations related to research activities. • Develops and leads oncology research activities that meet Mount Carmel Oncology ...
Clinical Research Coordinator I - IGM
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I - IGM
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I - RI Pulmonary Med
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I - RI Pulmonary Med
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I - RI Behav Trials Off
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I - RI Behav Trials Off
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I - RI Behav Trials Off
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Clinical Research Coordinator I - RI Behav Trials Off
Columbus, OH · On-site
$23.50 - $31.25/hr
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
... IRB, federal and state regulations; answers questions related to the protocol procedure as ... Such activities may be performed independently and may require evening and weekend hours.
Works with internal resources, Advarra or EPIC, where appropriate, to ensure issues are resolved in a timely manner including but not limited to departmental reports, IRB integrations and data ...
Works with internal resources, Advarra or EPIC, where appropriate, to ensure issues are resolved in a timely manner including but not limited to departmental reports, IRB integrations and data ...
Recruits, consents, and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations, and departmental quality control guidelines.
Recruits, consents, and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations, and departmental quality control guidelines.
Sr. Clinical Research Associate
Delaware, OH · On-site +1
Ensure study conduct is executed according to the clinical protocol, regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs. * Prioritize patient safety, ensuring informed ...
Sr. Clinical Research Associate
Delaware, OH · On-site +1
Ensure study conduct is executed according to the clinical protocol, regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs. * Prioritize patient safety, ensuring informed ...
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Senior Research Regulatory Coordinator - RI Gene Ther
Columbus, OH • On-site
Full-time
Posted 23 days ago
Nationwide Children's Hospital rating
6.9
Based on 131 frontline employees who took The Breakroom Quiz
553rd of 1,064 rated hospitals
Job description
Overview:
Job Description Summary:
Coordinates the regulatory and compliance process of all clinical research conducted in the NCH/RI system. Oversees the preparation and submission of regulatory and compliance documents to study sponsors and assists with quality improvement initiatives. Coordinates submissions of human subjects research project to the Institutional Review Board (IRB) andof Investigational New Drug Applications (IND's) to the U.S. Food and Drug Administration (FDA).
Job Description:
Essential Functions:
Education Requirement:
Bachelor's degree or equivalent experience in medical/science field.
Licensure Requirement:
(not specified)
Certifications:
CCRP certification preferred.
Skills:
Knowledge of medical terminology and diseases, preferred.
Excellent computer skills.
Ability to multi-task with strong organizational and prioritization skills.
Strong attention to detail.
Customer focused personality.
Working knowledge of IRB and regulatory processes and systems.
Current knowledge of Federal regulations (FDA, GCP, NIH, DHHS, ICH GCP), and study protocols.
Experience:
Two years Clinical Research Experience, required.
Physical Requirements:
OCCASIONALLY: Bend/twist, Driving motor vehicles (work required) *additional testing may be required, Reaching above shoulder, Squat/kneel
FREQUENTLY: Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Sitting, Standing, Walking
CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing - Far/near
Additional Physical Requirements performed but not listed above:
(not specified)
"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"
Job Description Summary:
Coordinates the regulatory and compliance process of all clinical research conducted in the NCH/RI system. Oversees the preparation and submission of regulatory and compliance documents to study sponsors and assists with quality improvement initiatives. Coordinates submissions of human subjects research project to the Institutional Review Board (IRB) andof Investigational New Drug Applications (IND's) to the U.S. Food and Drug Administration (FDA).
Job Description:
Essential Functions:
- Reviews study protocols in order to write consent/assent documents and develop the initial IRB submission; submits protocol amendments; responds to contingencies and obtains final approval of documents from sponsor and IRB, on behalf of principal investigator.
- Serves as liaison between study sponsors and the research team (IRB, research staff and Principal Investigator) regarding regulatory matters in the IRB submission and approval process.
- Responsible for the preparation, submission and maintenance of documents and processes related to investigator-initiated drug/device projects. Serves as liaison with federal agencies as needed.
- Oversees the creation and maintenance of regulatory documents and the study administrative binder required for the clinical research project.
- Maintains current knowledge of federal research regulations by reviewing current publications and attending conferences. Advises management of regulation changes and projected impact within Clinical Research Services and the institution.
- Primary resource to provide guidance to investigators and research staff on federal regulations, good clinical practices and IRB policies and systems. Identifies protocol content which may conflict with federal and/or local requirements or practice.
- Assists with quality improvement audits, including the administrative binder, subject research records, case report forms and other study documents.
- Responsible for data required for CCTS annual report and other metrics as required.
Education Requirement:
Bachelor's degree or equivalent experience in medical/science field.
Licensure Requirement:
(not specified)
Certifications:
CCRP certification preferred.
Skills:
Knowledge of medical terminology and diseases, preferred.
Excellent computer skills.
Ability to multi-task with strong organizational and prioritization skills.
Strong attention to detail.
Customer focused personality.
Working knowledge of IRB and regulatory processes and systems.
Current knowledge of Federal regulations (FDA, GCP, NIH, DHHS, ICH GCP), and study protocols.
Experience:
Two years Clinical Research Experience, required.
Physical Requirements:
OCCASIONALLY: Bend/twist, Driving motor vehicles (work required) *additional testing may be required, Reaching above shoulder, Squat/kneel
FREQUENTLY: Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Sitting, Standing, Walking
CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing - Far/near
Additional Physical Requirements performed but not listed above:
(not specified)
"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"
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About Nationwide Children's Hospital
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Nationwide Children's Hospital, established in 1894, is a leading pediatric healthcare system based in Columbus, Ohio, United States. They serve as a primary pediatric network, providing wellness, preventive, diagnostic, treatment, and rehabilitative care for infants, children, adolescents, and adults with congenital disease. Being the third-largest pediatric hospital in the nation, Nationwide Children's Hospital prides itself on its relentless commitment to children and their families, driven by their core values of respect, integrity, determination, empathy, and solidarity. The institution's comprehensive mission is to enhance the health of children by providing high-quality, family-centered care, conducting groundbreaking research, advocating for pediatric health, and training top healthcare professionals.
Industry
Hospitals
Company size
10,000+ Employees
Headquarters location
Columbus, OH, US
Year founded
1892