Regulatory Specialist - Oncology Research

Regulatory Specialist - Oncology Research

Alliance Community Hospital | Canton, OH, 44702, US
Salary Range:$52,000 – $71,000 Salary range estimated by Zippia

Posted 10 days ago

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Description

The Research Regulatory Specialist assumes a key role for all research studies conducted at Aultman Hospital.# Primary responsibilities include planning, completing and submitting regulatory documents for industry and federal sponsored studies. # RESPONSIBILITIES # EXPECTATIONS Performs a variety of diverse, high-level administrative and functional tasks requiring analysis and knowledge of study protocols, federal, local, and Institutional Review Board (IRB) regulations/policies. Regularly communicates with Aultman Investigators, staff and sponsor representatives. Prepares for and participates in all research related site visits (Site qualification, site initiation, routine monitoring, regulatory audit, ect.) Submits and maintains IRB records for each protocol (i.e. study start up, amendment, change in study status, continuing review, study close out, and other correspondence) Tracks study approval and expiration statuses. Under the direction of the Physician Investigator is responsible for the preparation and maintenance of the following regulatory documents: FDA Form 1572 Researcher CV#s and licenses Other researcher credentials (CTEP registration, training certificates, etc.) Conflict of interest documentation IRB submissions and related correspondence, reports and letters Documentation of training Logs including delegation of tasks, protocol and consent document versions, Investigational Brochures, enrollment logs, monitoring visit logs, etc.). Maintains quality control documents (i.e. calibration records, temperature monitoring, training records, licenses, and certifications) Drafts consent form modifications in compliance with sponsor direction, IRB policy and HIPAA regulations Logs and manages Safety Reports.# Coordinates Investigator review and sign-off. Prepares for and attends Protocol Subcommittee meetings Performs quality assurance reviews to confirm all regulatory documents are compliant with local Standard Operating Procedures (SOP#s), local and federal regulations, and Good Clinical Practice. Participates in department meetings, educational activities and programs Creates and fosters a work environment that is consistent with the Mission, Vision and Values of the Aultman Health Foundation. Supports strategic organizational goals. Abides by the Aultman Code of Conduct at all times. # # Job Requirements # High School Diploma, or higher Requires a working knowledge of computer applications. Research and/or healthcare related field experience preferred, but site is willing to train. Completes required training as assigned: HIPAA training (annually) Ethics training Good Clinical Practice training (every three years) Standard Operating Procedure review (as assigned) Ability to multi-task and work independently with minimal supervision with diverse teams of people in a diplomatic, collaborative and effective manner. Excellent time management and organization skills Ability to work well under time constraints and meet deadlines. Problem solving and conflict resolution skills. Detail-oriented with excellent communication skills (both oral and written). # All qualified applicants will receive consideration for employment without regard to#race, color, religion, sex, age, national origin, disability, or veteran status.# WORKING CONDITIONS: Expected to work assigned days Monday-Friday, day shift in accordance with approved FTE.# Flexibility in schedule may be required. Must be willing to work or cover off-shifts/weekends and holidays as necessary. Subject to frequent interruptions and changes in priority of duties throughout the day. Sitting/standing/moving about during working hours# # # # PHYSICAL REQUIREMENTS ADDENDUM # O = Occasionally = 0- 33% of the work shift or## 0- 32## repetitions. F = Frequently = 34-66% of the work shift or 32-200+ repetitions.## C = Constantly = 67-100% of the work shift or 200+ repetitions. N = Not essential job requirement.

The Research Regulatory Specialist assumes a key role for all research studies conducted at Aultman Hospital. Primary responsibilities include planning, completing and submitting regulatory documents for industry and federal sponsored studies.

RESPONSIBILITIES & EXPECTATIONS

* Performs a variety of diverse, high-level administrative and functional tasks requiring analysis and knowledge of study protocols, federal, local, and Institutional Review Board (IRB) regulations/policies.
* Regularly communicates with Aultman Investigators, staff and sponsor representatives.
* Prepares for and participates in all research related site visits (Site qualification, site initiation, routine monitoring, regulatory audit, ect.)
* Submits and maintains IRB records for each protocol (i.e. study start up, amendment, change in study status, continuing review, study close out, and other correspondence)
* Tracks study approval and expiration statuses.
* Under the direction of the Physician Investigator is responsible for the preparation and maintenance of the following regulatory documents:
* FDA Form 1572
* Researcher CV's and licenses
* Other researcher credentials (CTEP registration, training certificates, etc.)
* Conflict of interest documentation
* IRB submissions and related correspondence, reports and letters
* Documentation of training
* Logs including delegation of tasks, protocol and consent document versions, Investigational Brochures, enrollment logs, monitoring visit logs, etc.).
* Maintains quality control documents (i.e. calibration records, temperature monitoring, training records, licenses, and certifications)
* Drafts consent form modifications in compliance with sponsor direction, IRB policy and HIPAA regulations
* Logs and manages Safety Reports. Coordinates Investigator review and sign-off.
* Prepares for and attends Protocol Subcommittee meetings
* Performs quality assurance reviews to confirm all regulatory documents are compliant with local Standard Operating Procedures (SOP's), local and federal regulations, and Good Clinical Practice.
* Participates in department meetings, educational activities and programs
* Creates and fosters a work environment that is consistent with the Mission, Vision and Values of the Aultman Health Foundation.
* Supports strategic organizational goals.
* Abides by the Aultman Code of Conduct at all times.

Job Requirements

* High School Diploma, or higher
* Requires a working knowledge of computer applications.
* Research and/or healthcare related field experience preferred, but site is willing to train.
* Completes required training as assigned:
* HIPAA training (annually)
* Ethics training
* Good Clinical Practice training (every three years)
* Standard Operating Procedure review (as assigned)


* Ability to multi-task and work independently with minimal supervision with diverse teams of people in a diplomatic, collaborative and effective manner.
* Excellent time management and organization skills
* Ability to work well under time constraints and meet deadlines.
* Problem solving and conflict resolution skills.
* Detail-oriented with excellent communication skills (both oral and written).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, or veteran status.

WORKING CONDITIONS:

* Expected to work assigned days Monday-Friday, day shift in accordance with approved FTE. Flexibility in schedule may be required.
* Must be willing to work or cover off-shifts/weekends and holidays as necessary.
* Subject to frequent interruptions and changes in priority of duties throughout the day.
* Sitting/standing/moving about during working hours

PHYSICAL REQUIREMENTS ADDENDUM

O = Occasionally = 0- 33% of the work shift or 0- 32 repetitions.

F = Frequently = 34-66% of the work shift or 32-200+ repetitions.

C = Constantly = 67-100% of the work shift or 200+ repetitions.

N = Not essential job requirement.