Position Objective: Provide services as a Clinical Protocol Coordinator (Clinical Trials) in support of the overall functions of the Division of Allergy, Immunology and Transplantation (DAIT), Allergy, Asthma, and Airway Biology Branch (AAABB) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• Provide support to clinical investigators and their staff in the development of clinical trial and observational study protocols and informed consent forms.
• Provide support to clinical investigators and their staff in the development and implementation of study SOPs.
• Oversee clinical trials and large observational studies, e.g., track and report on study milestones, oversee site monitoring activities, and review site monitoring reports.
• Train and educate clinical site staff about protocol procedures, informed consent processes, regulatory aspects of research and GCP compliance.
• Work with CRAs or other extramural workers to monitor sites for regulatory compliance, e.g. site and staff licensing.
• Work with CRAs or other extramural workers to monitor sites for protocol compliance, e.g., review site reports.
• Provide guidance to site staff throughout the course of a clinical or observational study.
• Develop and maintain internal documents for clinical trials not supported by Clinical Research Organizations.
• Overall, during study development and throughout the duration of a clinical study, provide guidance and recommendations to investigators and their staff, as well as to other DAIT/NIAID staff involved in the study.

Basic Qualifications:

• RN, NP, PA or MD degrees (practicing license not necessary).
• Minimum of three (3) years recent experience in managing, conducting or monitoring clinical trials.
• Current GCP training.
• Experience in clinical data management.
• Familiarity with IRB requirements.

Minimum Qualifications:

• Excellent writing skills.
• 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.