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Human Regulatory Protections Manager

Company: Clinical Research Management
Location: Silver Spring
Posted on: June 6, 2021

Job Description:

ICON Government and Public Health specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.

Position Summary:

S/he is responsible for the direction, operation, and management of the Regulatory Affairs and Research Compliance program. S/he will ensure compliance of research programs with applicable sponsor, local, state and federal regulations for human subject research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA).

Essential functions:

Reasonable Accommodation Statement:

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.

  • Under government guidance, the contractor is responsible for the operation and management of the Regulatory Affairs and Research Compliance program.
  • Ensures compliance of research programs with applicable sponsor, local, state and federal regulations for human subject research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA).
  • Assists in the development and updating of the DVBIC regulatory compliance policies, standard operating procedures, requirements and related matters.
  • Establishes training programs in human subject protection and HIPAA compliance.
  • Conducts research compliance monitoring.
  • Obtains Scientific review of proposals and protocols.
  • Facilitate information flow and acts as liaison between agencies such as USUHS, Federal and Contractor Principal Investigators and research staff, administrative staff, Institutional Review Boards (IRBs), Institutional Animal Care and Use Committees (IACUCs) Institutional Bio-safety Committees (IBCs), research administration offices, Food and Drug Administration (FDA), Office of Human Research Protections (OHRP).
  • May conduct site monitoring visits to ensure compliance with regulations and human subjects protection.
  • May supervise their assistant.
  • Maintains a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
  • Performs light duties and other related duties as required and assigned.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May encounter patients who are confused, agitated, or abusive.

WORK ENVIRONMENT:

Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.

Keywords: Clinical Research Management, Silver Spring , Human Regulatory Protections Manager, Other , Silver Spring, Maryland

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