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Clinical Advisor (ACTIV-2)

Company: GAP Solutions, Inc
Location: Bethesda
Posted on: June 6, 2021

Job Description:

Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS (DAIDS), Therapeutics Research Program (TRP) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

  • Create and facilitate implementation of an overall operational plan for the ACTIV 2 family of studies, including timeline, key milestones, resources needed and budget. The ACTIV 2 study is the U.S. Government's premier effort to develop data on promising therapies for outpatients suffering from COVID-19 disease. The study is a complex platform study, capable of testing multiple investigational products simultaneously. It is an adaptive design spanning traditional phase 2 and phase 3 of clinical development. It is being conducted under the auspices of the NIH, and the NIH-funded AIDS Clinical Trial Group (ACTG).
  • Assess the operational feasibility and resource considerations of new entrants to the trial.
  • Working through established contract resource organizations and with the sponsor and networks:

a. Create a global site/country strategy Oversee the execution of that strategy including site selection including feasibility, qualification and pre-study assessment

b. Oversee site activation including, the provision of investigational product, non-IP clinical supplies and laboratory materials; the completion of required regulatory documentation and the granting of needed systems access.

c. Coordinate efforts to recruit participants into the trial including global trial and site specific recruitment plans, media and outreach programs and vendor programs.

d. Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed.

e. Oversee the executions of the data management plan. Ensure that queries are resolved and database closure occurs on time.

f. Oversee the study close-out plan.

  • Create and oversee the execution of a study risk management plan. Proactively resolve risks to operational delivery.
  • Lead team meetings.
  • Support meeting documentation and follow-up action items.
  • Facilitate reporting of study status to key stakeholders in NIH, Operation Warp Speed, and the ACTG.

Basic Qualifications:

  • Bachelor's Degree required in scientific discipline
  • Minimum of ten (10) years of related experience

Minimum Qualifications:

  • Ability to communicate effectively, orally and in writing, with non-technical and technical staff
  • Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.

Keywords: GAP Solutions, Inc, Bethesda , Clinical Advisor (ACTIV-2), Other , Bethesda, Maryland

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