Orem, Utah
Clinical Research - Regulatory Affairs/IRB Specialist Job Opening in Orem, Utah - Must be familiar with the clinical research / pharmaceutical industry and be willing to "Stay Drama Free" while working at Aspen!
Willing to work out of our Orem, Utah location ( no telecommuting )
In of need an energetic and motivated individual to come on to our team, to remain agnostic as it relates to drama, enjoys a challenge and likes to be on the cutting edge of what the pipeline of pharmaceuticals and medical devices have to offer future generations!
Essential Job Functions:
Completes and submits all essential documentation related to protocol specific study start-up with the Sponsor/CRO and the IRB. This includes completing and submitting:
FDA 1572
Signed Protocol Signature Page
Financial Disclosure Forms (FDF) for all site personnel listed in box 5 of the FDA 1572
IRB Study Site Submission Form (and any other supporting IRB documents)
Signed CVs and Medical Licenses of all site personnel listed in box 5 of the FDA 1572
Signed Investigator Brochure (IB) Acknowledgement Page (if applicable)
Any other documentation specified by the Sponsor/CRO and/or IRB
Reviews and submits protocol specific Informed Consent Form (ICF) if changes are required
Any study specific site personnel training information
Compiles, updates and maintains the Investigator Site File (ISF) Binder for all protocols at the study site. This includes, but is not limited to:
All protocol specific study information according to the Investigator Site File (ISF) Table of Contents (ISF-TOC)
Receiving, circulating and reconciling all protocol specific IND Safety Reports for the Investigational Product being tested
Receiving, circulating and reconciling all protocol specific Protocol amendments, Informed Consent Forms (ICFs), Investigator Brochures (IB), Newsletters, and monitoring visit confirmation and follow-up letters.
Breaks down and files all ISF Binders for studies that have been completed and closed.
After receiving the protocol specific deviation/violation memos to file from the Clinical Research Coordinator (CRC), completes and submits the required IRB submission form. Verifies IRB acknowledgement of the protocol deviation/violation according to IRB and/or Sponsor/CRO requirements.
Receives, distributes, files and tracks all protocol specific Informed Consent Forms (ICFs) during the study according to Aspen Standard Operating Procedures (SOP).
Assists with completing, updating and distributing all SOPs and associated forms when needed.
Other Job Functions:
Assists in the performance of other regulatory functions within the Compliance section of the Regulatory department (e.g., Contract GCP audits)
Works with Sponsor/CRO monitors in identifying and resolving all deficiencies related to the ISF Binder
Assists with the development of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
Any other duties as determined by the executive team
Adheres to required company training plans
QUALIFICATIONS:
Knowledge, Education, and Experience:
B.S. or graduate from an accredited four-year university/college or equivalent with course work relevant to the medical and healthcare field or relevant experience in the industry.
Minimum of one year direct experience in the Site, Sponsor, CRO industry or Biomedical field.
*Skills and Abilities:
*
Good communication skills and the ability to perform independently
Strong interpersonal and conceptual skills are essential as well as the demonstrated ability to appropriately apply scientific, regulatory, and administrative knowledge to accomplish research goals
Must be computer literate and have a working knowledge of commercial software programs currently in use i.e. MS Word, MS Excel, Salesforce platform software (CTMS system), PDF programs, online portal you will be trained on, etc.
Equipment and Materials Used:
Computer, copiers, scanner, fax (yes, a fax machine is still in use), phone, general office equipment
Other Working Conditions:
Potential for high stress, with changing priorities and timelines of our customers.
We need an energetic and motivated individual to come on to our team, to remain agnostic as it relates to drama, enjoys a challenge and likes to be on the cutting edge of what the pipeline of pharmaceuticals and medical devices have to offer future generations!
Job Type: Full-time
Salary: $28,000.00 /year
Job Location:
Orem, UT 84058
Required education:
Associate
Required experience:
Clinical Research field: 2 years
Regulatory Affairs: 1 year
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