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Quality Management Specialist (COVID-19)– Infectious Disease Clinical Research Program

Company: Henry M Jackson Foundation For The Advan
Location: Bethesda
Posted on: September 13, 2020

Job Description:

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Quality Management Specialist (COVID-19)– Infectious Disease Clinical Research Program HJF is seeking a Quality Management Specialist (COVID-19) to support the Infectious Disease Clinical Research Program (IDCRP) located in Bethesda, MD. HJF provides scientific, technical and programmatic support services to IDCRP.

The incumbent assists the Chief of Quality Management to ensure regulatory compliance, data quality, and consistency of protocol execution and management across the IDCRP multisite clinical research network.

Responsibilities:

Under the supervision of the IDCRP Chief of Quality Management, assists in the development, implementation, and management of study-specific Quality Management Plans, including quality assurance and quality control activities. Assists in the establishment of a Program-wide Quality Management Program to ensure regulatory compliance, data quality, and consistency. (25%)

In collaboration with the IDCRP Quality Management and Regulatory Affairs Team, performs routine quality assurance visits and internal audits of protocols and processes. Participates in external quality and regulatory affairs inspections/audits and assures that appropriate corrective actions are implemented. Verifies that the rights and wellbeing of subjects are protected; trial data are accurate, complete and verifiable from source documents; and processes are conducted according to protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), quality management standards, and other applicable regulatory requirements. (25%)

Supports the development and maintenance of IDCRP SOPs related to quality management and regulatory affairs. Conducts quality assurance reviews of other IDCRP SOPs, ensuring SOP availability, training, and documentation of compliance. Assists in maintaining a centralized documentation system for all records. (15%)

Contributes to the development and maintenance of QM and regulatory affairs training materials related to the design, execution, and management of IDCRP protocols. (15%)

Prepares agendas and meeting minutes for clinical research operations meetings in collaboration with the Chief of Quality Management. (10%)

Participates in regular communications with the IDCRP Quality Management and Regulatory Affairs Team, USU HRPPO, USU IRB, and HJF Office of Regulatory Affairs and Research Compliance, and engages with protocol monitors, sponsors, auditors, and others as appropriate. (10%)

May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities: Outstanding interpersonal and oral and written communication skills and excellent attention to detail required. Experience working collaboratively on multi-disciplinary teams and being a problem-solver required. Department of Defense (DoD) research experience preferred.

Minimum Education: Bachelor’s degree in Health Sciences, Clinical Research, or related field required.

Minimum Experience/ Training Requirements: 3-5 years of experience in clinical research, including conducting quality management and regulatory affairs activities, working with IRBs, and clinical study monitoring required.

Required Licenses, Certification or Registration: Clinical research professional certification (CCRC, CCRP, CIP, QSM, etc.) preferred.

Work Environment: Set in an office environment. Occasional travel to clinical study sites required.

Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Travel Required Yes . Occasional travel to clinical study sites required.

Qualifications Education Required

Bachelors or better.

Experience Required

3-5 years: 3-5 years of experience in clinical research, including conducting quality management and regulatory affairs activities, working with IRBs, and clinical study monitoring required.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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Keywords: Henry M Jackson Foundation For The Advan, Bethesda , Quality Management Specialist (COVID-19)– Infectious Disease Clinical Research Program, Other , Bethesda, Maryland

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