Clinical Advisor

Overview

We are seeking a Clinical Advisor to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member.

Accelerate your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security;

and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

• Process and perform quality control of expedited and non-expedited Serious Adverse Event (SAE), Adverse Events of Special Interest (AESIs), Pregnancy, Aggregate and Signal Detection Reports for all DAIT clinical trials for consistency, reportability, completeness and accuracy.

• Assist in the preparation of written reports of SAE, AESI, Pregnancy, Aggregate, and Signal Detection as needed for review by DAIT Medical Monitors, Clinical Research Operations Program (CROP) or NIAID safety oversight groups, boards or Monitors.

• Review the safety portions of proposed DAIT clinical protocols.

• Create and review protocol-specific Safety Management Plans (SMPs) for each DAIT protocol.

• Create and implement the workflow for Submission of Safety Reports in the Health Authorities outside the United States, as necessary.

• Participate in creating and updating safety policies and procedures for DAIT, as needed, such as updating the overall DAIT SMP used for all DAIT network trials, the network protocol-specific SMP template, and SMP template for non-network (Investigator-Initiated) and other trials as regulations evolve.

• Assist in the design, evaluation, troubleshooting and maintenance of IT systems supporting the CROP Safety/Pharmacovigilance and related programs.

• Participate as required in the review of the safety section of Clinical Trial Agreement.

• Work with Medical monitors and members safety desk at DAIT data centers to resolve queries, and other issues related to safety.

• Carry out other DAIT safety/pharmacovigilance program activities as directed by CROP Safety Lead, the CROP Director, or their designee.

• Fully function as the secondary CROP Safety Lead and/or backup for the CROP Safety Lead, as directed by the CROP Safety Lead, the CROP Director, or their designee.

• Review abstracted protocol information, including intervention information, entered into the DAIT Clinical Information System (NIAID CRMS (DAIT)) for completeness and correctness.

• Manage posting requirements and timelines for DAIT study results on Clinical trials.gov with DAIT program staff and relevant data centers.

• Manage and track new DAIT studies for registration on Clinical trials.gov and keep existing records up to date.

• As directed, create or assist with tracking and reporting of quality documentation, metrics and reporting.

• As directed, gather data on quality metrics and assist CROP personnel in fulfilling their obligations under the quality plan.

• As directed, query and obtain quality-related information, procedures and metrics from DAIT awardees.

• Create and edit CAPA documents and track their development and implementation.

• Write and review quality-related documents, including but not limited to process descriptions, process flow diagrams, Standard Operating Procedures (SOPs) and Project Work Instructions (PWIs).

• Function as a back-up for the DAIT Clinical…