Clinical Research Specialist

2 months ago

Stamford, Connecticut, United States NUES Inc Full time
Job Overview

Position Summary:

The Clinical Research Specialist will serve as a pivotal member of the research team, assisting principal investigators in the execution of institutionally sanctioned research protocols. This role encompasses a variety of responsibilities aimed at ensuring the successful management and compliance of clinical studies.

  • Determine the necessary documentation and processes to finalize the research protocol.
  • Refine the specific aims, hypotheses, and objectives of the proposed study.
  • Facilitate statistical and scientific consultations with relevant staff.
  • Create a tailored timeline for each research protocol.
  • Prepare essential documents for approval, including informed consent forms, recruitment materials, and data collection tools.
  • Coordinate administrative and ethical approvals for proposed research protocols.
  • Maintain up-to-date NIH and CITI training in line with local ethical review board policies.
  • Organize and prioritize activities related to phase I, II, and III clinical trials within a military context.
  • Review biomedical research protocols to ensure compliance with applicable regulations and guidelines.
  • Develop source documents for assigned studies, manage data collection, and ensure proper identification and reporting of Adverse Events (AEs).
  • Input required data into paper or electronic case report forms (CRFs), audit records for accuracy, and resolve discrepancies as needed.
  • Collect and maintain all essential documents for regulatory study files.
  • Collaborate with external monitors and internal quality assurance teams to ensure adherence to protocols and regulations.
  • Conduct evaluations of protocols and feasibility assessments for proposed clinical research.
  • Prepare necessary documentation for submission to the Institutional Review Board (IRB).
  • Create patient information and informed consent documents as well as recruitment materials.
  • Engage with potential research participants to explain the study in detail and secure informed consent.
  • Communicate with the IRB point of contact to maintain protocol renewals and fulfill interim reporting requirements.
  • Provide internal assessments of compliance with approved protocols and relevant regulations under the guidance of the Principal Investigator (PI).
  • Support the oversight of the quality assurance program to ensure compliance with applicable regulations in clinical trials and research activities.
  • Develop clinical quality management plans and materials to support the research program.
  • Review and evaluate existing quality assurance efforts in clinical research.
  • Assess adherence to protocols and relevant regulations.
  • Conduct routine audits of clinical study documentation to ensure compliance.
  • Identify deviations from protocols and recommend corrective actions.
  • Document resolutions of findings and report non-compliance to appropriate parties.

Additional Responsibilities:

  • Develop and implement Standard Operating Procedures (SOPs) as necessary.
  • Prepare compliance documents and tools for assessment.
  • Act as a liaison between study sponsors, investigators, and research personnel.
  • Independently create training materials and educate staff on research protocols and procedures.
  • Provide patient education regarding study participation and requirements.
  • Coordinate research personnel activities to ensure quality patient care and adherence to Good Clinical Practice (GCP) principles.
  • Focus on the safety considerations of research study patients.
  • Collaborate with multidisciplinary teams to provide nursing care in a research setting.
  • Utilize nursing expertise to identify patient care issues and develop care plans.
  • Assist in the administration of procedures related to research operations and quality improvement.
  • Manage the document control system, ensuring proper tracking and distribution of SOPs.
  • Support regulatory readiness and participate in inspections as needed.
  • Deliver training in quality assurance for clinical studies and maintain competency documentation.

Qualifications:

Education:

  • Bachelor of Science in Nursing (BSN) from an accredited program.
  • Master's degree preferred.
  • Certification in Research Nursing is recommended but not mandatory for hire.

Experience:

  • Preferred 5 years of experience in clinical, translational, and military research.

Knowledge:

  • Comprehensive understanding of biomedical research protocols and relevant regulations.
  • Familiarity with IRB and IACUC research protocols and processes.

Job Type:

On-Site

Company Overview

NUES Inc is committed to equal employment opportunities and affirmative action in all employment practices. We do not discriminate based on race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity, or any other legally protected category. All applicants must be legally authorized to work in the country of application, and verification of employment eligibility will be required as a condition of hire.

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