Regulatory Specialist | Rapid City Hospital | As Needed

Current Employees:
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Starting Pay Rate Range
$18.74
to
$23.43
(Determined by the knowledge, skills, and experience of the applicant.)
Job Summary
Responsible for the organization, completion, and management of regulatory documents, including management of all Institutional Review Board submissions, and general office coordination. Participate with other team members on the development, implementation and continued evolution of systems that ensure adherence to research protocols, institutional policies, local/state/ federal regulations and "Good Clinical Practices" The role interacts with all areas and personnel of the research department and it is necessary to coordinate, prioritize and provide oversight over numerous activities at once. There is frequent communication via phone, fax, and e-mail with other departments, research organizations, sponsors and academic organizations. Establish and maintain effective working relationships with team members, extended Healthcare providers, clinical research organizations and regulatory agencies to ensure the safe and effective care of those who volunteer to be participants in clinical research.
Monument Health offers competitive wages and benefits on qualifying positions. Some of those benefits can include:
*Supportive work culture
*Medical, Vision and Dental Coverage
*Retirement Plans, Health Savings Account, and Flexible Spending Account
*Instant pay is available for qualifying positions
*Paid Time Off Accrual Bank
*Opportunities for growth and advancement
*Tuition assistance/reimbursement
*Excellent pay differentials on qualifying positions (extra pay for working evening, nights or weekends)
*Flexible scheduling
Job Description
Essential Functions:

• Assists in continuing education of physicians, residents, interns, nurses in updating their knowledge of clinical research activities.
• Coordinate efforts to receive needed IRB approvals from both internal (RCH) and external (Tribal and IHS) institutions.
• Organize and maintain files in long-term storage by creating and maintaining spreadsheets of boxes and inventory, creating box labels, and overseeing file destruction and storage as per FDA guidelines.
• Prepares for record reviews and audits with on site teams, sponsors, FDA, or other agencies and sponsors when requested.
• Coordinates cancer research protocol reviews and other required documents for the hospital's "Institutional Review Board" (IRB).
• Develop documents and processes for successful trial implementation which are consistent with internal processes and procedures, regulatory requirements, and "Good Clinical Practice."
• Ensures compliance with hospital, IRB, HIPPA, and funding agency regulations.
• Establish system of accountability for investigational products and devices consistent with protocol and regulations.
• Facilitate site monitoring visits by assuring they have all the information and materials needed to effective perform their job, assisting them while on site, close-out visit with investigator, addressing action items in monitoring letter.
• Prepares IRB records for audit.
• All other duties as assigned.

Additional Requirements
Required:
Education - High School Diploma/GED Equivalent in General Studies
Preferred:
Experience - 1+ years of Healthcare Experience
Education - Some College (1-2 years) in Related Field
Physical Requirements:
Light work - Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Job Category
Education and Research
Job Family
Research
Department
RCH NCCTG
Scheduled Weekly Hours
0
Shift
Employee Type
PRN
10 Monument Health Rapid City Hospital, Inc.
Make a difference. Every day.
Monument Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.