Responsible for all onsite Clinical Trial activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Facilitate quality assurance monitoring by study sponsors. Relies on experience and judgment to plan and accomplish goals and tasks. Performs a variety of tasks. May lead and direct the work of others.
DESCRIPTION OF RESPONSIBILITIES:- Responsible for Quality Assurance/Regulatory Compliance of all onsite Clinical Trial activities
- Conducts audits and reviews/analyzes data and documentation. This includes internal audits such as the laboratory.
- Develops, maintains, and ensures compliance with Standard Operating Procedures (SOPs), be knowledgeable and compliant with all Human Subjects' Protection, FDA, and current Good Clinical Practice (GCPs) regulations as well as ensuring all contractor study personnel remain trained and up to date in their respective fields.
- Facilitates quality assurance monitoring by study sponsors.
- Relying on experience and judgment to plan and accomplish goals and tasks.
- Prepares and maintains instructions and pre-established guidelines to perform the functions of the job.
- Coordinates with entire Clinical Trials Center (CTC) team to ensure compliance for all studies regardless of study phase.
- Ensures successful completion of all internal and external audits, assists Clinical Research Coordinator (CRC) with regulatory compliance, maintains staff credentials, provides Quality Control of all source documents, conducts chart review, and updates SOPs as necessary.
- Prepares monthly status report and performs a variety of tasks. May lead/direct the work of others.
- Other duties as assigned by Supervisor.
REQUIRED DEGREE/EDUCATION/CERTIFICATION:- Must have an Associate's degree and four plus (4+) years of experience.
- Bachelor's degree is preferred.
- Minimum of five (5) years of experience in quality assurance for clinical trials, with expertise in ICH/GCP compliance.
- Certification in quality management (e.g., ASQ or equivalent) is preferred.
REQUIRED CITIZENSHIP AND CLEARANCE:- Must be able to pass a NACI for Common Access Card.
- Must be a U.S. Citizen.
COMPENSATION DETAILS:- $128,881.63 - 132,635.47
- The compensation range or hourly rate provided is a good faith estimate at the time of posting. Final compensation will be determined based on qualifications, experience, skills, internal equity, market conditions, and applicable laws.
Bering-Alaka`ina Holdings, LLC is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.
As a part of BSNC, Bering- Alakaina Holdings gives hiring, promotion, training, and retention preference to BSNC shareholders, descendants and shareholder spouses who meet the minimum qualifications for the job. Qualified job candidates will generally be considered in the following order: BSNC shareholders, descendants, shareholder spouses, current employees, and outside candidates. The BSNC Shareholder Development department tracks and monitors the implementation of the Shareholder Hire Preference across its operations.
Bering-Alaka`ina Holdings, LLC is comprised of industry-recognized government service firms designated as Alaska Native Corporation (ACN)-owned and 8(a) certified businesses and includes Ke`aki Technologies, LLC; Laulima Government Solutions, LLC; Kūpono Government Services, LLC; Kapili Services, LLC; Po`okela Solutions, LLC; Kīkaha Solutions, LLC; and Pololei Solutions, LLC.
For additional information, please visit www.beringalakaina.com
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