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.Responsibilities

• 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 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 aid 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.

• Other duties as assigned.

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.

Physical Requirements: The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

• Constantly perform sedentary work that primarily involves sitting/standing.
• Occasionally perform light work that includes moving objects up to 20 pounds.
• Occasionally perform medium work that includes moving objects up to 50 pounds.
• Occasionally push or pull less than 25 pounds.
• Rarely push or pull 25 — 45 pounds.
• Occasionally reach above shoulder level.
• Constantly use both hands.
• Occasionally stand or walk for more than 25 minutes and bend, reach, or twist repeatedly.
• Rarely will have to kneel, squat, or stoop.
• Rarely will have to crawl or climb.
• Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.
• Occasionally will move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information, and assess the accuracy, neatness and thoroughness of the work assigned.
• Occasionally will work in noisy environments.
• Constantly will work where no adverse environmental conditions expected.
• Occasionally will be required to wear PPE including but not limited to gloves, face shields/goggles, safety glasses, safety shoes and disposable dust/surgical mask.

Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

CAMRIS International