Clinical Advisor

Overview

• Axle is looking to add a driven, flexible, organized, and meticulous Clinical Advisor to our dynamic DAIT/CROP/Safety & Pharmacovigilance team. The Contractor(s) will independently offer services to support the DAIT/CROP/Safety & Pharmacovigilance overall functions. The main goal is to produce deliverables and services by performing support services. 

Technical Requirements: 

• 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 Clinicaltrials.gov with DAIT program staff and relevant data centers. 
• Manage and track new DAIT studies for registration on Clinicaltrials.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 Review Committee (DCRC) lead coordinator, with the capability of fully replacing the primary DAIT DCRC lead as required. These duties include but are not limited to: 
  • Receive requests for DCRC reviews of protocols, obtain commitments for DAIT Moderators for each protocol review, schedule DCRC meetings, including venues, notify DAIT staff of each DCRC meeting and arrange the electronic and telephonic meeting support for the meetings.
  • Manage the on-line and call-in portions of the DCRC meetings.
  • Solicit review comments from assigned reviewers and meeting participants and synthesize them into the post-meeting DCRC Memo.
  • Circulate the memo for revisions, track and notify reviewers as necessary of their pending review assignments. Circulate the final memo on behalf of the CROP Director.
  • Maintain DCRC Review files in a shared location and/or archive as directed. 
  • Maintain an up-to-date status tracker of all pending and on-going DCRC reviews.
  • Track protocols through the DAIT CRC review process to ensure that each new clinical trial receives at least one CRC review. 
  • Track the investigator responses that are received and reviewed by the DCRC. 
• Assist with production and review of other documents as needed. 
• Provide status reports to include information on current and completed activities; problems encountered; corrective actions taken; and recommendations for the next reporting period as requested by the Task Leader or their designee. 
• Upon request, the contractor shall provide documented evidence of any and all work products.
• Perform quality control support of SAEs, AESIs, Pregnancies, Aggregate, and Signal Detection Report tracking logs for all DAIT clinical trials, as well as the prepared written reports of the above reports. Perform assignments from the data center safety desks as needed. 
• Review of the safety section of the protocol, CTAs, and IT systems. 
• Write and edit of clinical or procedure-related documents including but not limited to Safety Management Plans, Standard Operating Procedures, PWIs, process flow documents and diagrams. 
• Perform necessary Quality-driven activities, data entry and quality monitoring. 
• Manage posting requirements and timelines for DAIT study results on Clinicaltrials.gov with DAIT program staff and relevant datacenters. 
• Collaborate with DAIT Offices or Branches to aide in CROP cross-Branch consistency, adherence to SOPs and other quality program requirements, and protocol consistency. 
• Develop quality documents, performing quality-driven activities and quality monitoring. 
• Serve as the backup coordinator for the DAIT Clinical and Research Committee meetings within DAIT, NIAID.
• Coordinate and schedule DCRC meetings and provide electronic/telephonic access to the meetings; ensure the timely production of the protocol-specific DCRC memos from the DCRC meetings; track and record the output from all DCRC meetings. 
• Participate in designing, evaluating, troubleshooting and maintaining DAIT/CROP IT systems as needed.
• Update and maintain tracking documents for DAIT CROP.

Specific Qualifications:

• Master’s degree in biology or health-related field or a related discipline. Three (3) years of specialized experience plus a BA/BS degree is equivalent to a Master’s degree. 
• Minimum of one (1) year of experience in clinical trial safety management/pharmacovigilance. 
• Expertise in the fundamentals of clinical trials, including ICH Guidelines, including E (R2) - GCP regulations, and Human Subject Protection. 
• Expertise in clinical pharmacovigilance and drug safety, including CTCAE grading, MedRDRA coding, WHO Drug Dictionary. 
• Expertise in clinical trial drug safety regulations and guidelines in US, Canada, Australia, and UK. Familiarity with signal detection and pharmacoepidemiology. 
• Familiarity with safety and pharmacovigilance databases such as Oracle Argus. 
• Experience in clinical data management, database operations and analysis. 
• Basic understanding of human anatomy and general medical terms, physical diagnosis, and disease pathogenesis. 
• Expertise in MS Office including; Word, Excel, Outlook, PowerPoint, OneNote and Visio. 
• Strong communication skills, both oral and written. 
• Experience working in a quality-based environment.