1+ months

Clinical Advisor

MSC
Bethesda, MD 20814

Overview

We blend deep domain expertise in health IT, life sciences, public safety, and grants management with advanced technologies to help Federal agencies solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to cultivate a culture of innovation, customer success, and employee growth.

Duties & Responsibilities

MSC is searching for a Clinical Advisor to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, Maryland.

 

  • 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 division 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 division Medical Monitors, Clinical Research Operations Program (CROP) or Institute safety oversight groups, boards or Monitors.
  • Review the safety portions of proposed division clinical protocols.
  • Create and review protocol-specific Safety Management Plans(SMPs) for each division 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 the division, as needed, such as updating the overall division SMP used for all division 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 division data centers to resolve queries, and other issues related to safety.
  • Carry out other division 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 division Clinical Information System for completeness and correctness.
    • Manage posting requirements and timelines for division study results on Clinicaltrials.gov with division program staff and relevant data centers.
    • Manage and track new division 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 division 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 division Clinical Review Committee (DCRC) lead coordinator, with the capability of fully replacing the primary DCRC lead as required. These duties include but are not limited to:
      • Receive requests for DCRC reviews of protocols, obtain commitments for Moderators for each protocol review, schedule DCRC meetings, including venues, notify 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 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 study results on Clinicaltrials.gov with program staff and relevant datacenters.
  • Collaborate with division 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 divisions Clinical and Research Committee meetings within the division; 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 IT systems as needed.
  • Update and maintain tracking documents for CROP.

Requirements

 

  • Masters degree in biology or health-related field or a related discipline. Three (3) years of specialized experience plus a Bachelors degree is equivalent to a Masters degree.
  • Minimum of one (1) year of experience in clinical trial safety management or 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.

 

Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Categories

Posted: 2020-06-11 Expires: 2020-10-08

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Advisor

MSC
Bethesda, MD 20814

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast