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:
- Lead the creation, implementation and appropriate closeout of an overall operational plan for one or more treatment studies including COVID-19 trials. Activities may include but not limited to timeline, key milestones, resources needed and budget.
- Assess the operational feasibility and resource considerations of new entrants to said trials.
- Work through established contract resource organizations and with the sponsor, networks and company partners:
- Create a global site/country strategy
- Oversee the execution of that strategy including site selection including feasibility, qualification and pre-study assessment
- 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.
- Coordinate efforts to recruit participants into the trial including global trial and site specific recruitment plans, media and outreach programs and vendor programs.
- Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed.
- Oversee the executions of the data management plan. Ensure that queries are resolved and database closure occurs on time.
- Oversee the study close-out plan.
- As needed, review processes (or lead a team that reviews the processes) that relate to or impact any of the above items and work with implementing partners to revise SOPs, process pathways, and implementation plans to effect more efficient or rapid outcomes.
- Create and oversee the execution of a study risk management plan. Proactively resolve risks to operational delivery.
- Support meeting documentation and follow-up action items.
- Facilitate reporting of study status to key stakeholders in the US Government including NIH, the ACTG, and other partners/collaborators.
Basic Qualifications:
- B.S./B.A. degree in a related field.
- 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
*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, email 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.
