Position Objective: Provide services as a Clinical Research Coordinator (Bilingual/Spanish) in support of the overall functions of the Director of Intramural Research (DIR), Laboratory of Host Immunity and Microbiome (LHIM) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• Manage, coordinate and implement all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting.
• Assist study team members in developing an understanding of study design and rationale and support team members in implementation and study procedures.
• Anticipate and mitigate risks and unplanned circumstances impacting patient qualification and data collection.
• Provide technical experience needed to manage the administrative functions within the clinic.
• Establish relationships with non-research departments as needed for essential workflow within the clinical departments.
• Design recruitment and retention plans to support the study.
• Work to implement the policies and procedures of the program with the clinical research team.
• Supply study progress metrics for weekly reporting.
• Ensure ICH GCP compliance with execution of protocols, patient enrollment and follow up, adverse event tracking and study activities.
• Design and implement quality assurance and quality control procedures within the day to day research activities.
• Coordinate with study monitors for site visits and query resolution.
• Monitor efficiency of procedures and contribute to the development of SOPs and internal processes to enhance the quality of study conduct.
• Ensure ICH GCP compliance with execution of protocols, patient enrollment and follow up, adverse event management and reporting and study activities.
• Demonstrate skills in navigating and troubleshooting a wide variety of e-clinical technologies.
• Maintain site-level regulatory documentation.
• Request and initiate the purchase of materials, supplies and equipment.

Basic Qualifications:

• Bachelor’s degree in a related discipline.
• Minimum of at least 5 years of clinical research experience and 2 years of team lead experience.
• Minimum of seven (7) years of working experience in a related field.
• Phlebotomy skills required.
• Demonstrates experience working in a clinical environment.
• Demonstrates experience with program and protocol management, and budget tracking.
• Primary work location will be in Northern Virginia (Inova Fairfax Hospital).

Minimum Qualifications:

• Bilingual Spanish speaker preferred.
• 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.