Clinical Research Coordinator

Position Information:

Provide scientific staffing support for the Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID)

Additional Qualifications:

Certifications & Licenses

• Bilingual Spanish speaker preferred

Field of Study

• Health and Medical Administrative Services

Software

• MS Office

Skills

• Minimum of at least 5 years of clinical research experience and 2 years of team lead experience

Deliverables:

• Run Validation - Monthly

• Meet with lab members to present updates - Daily

Statement of Work Details:

• Assist, coordinate and implement all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting. - 1
• Assist study team members in developing an understanding of study design and rationale and support team members in implementation and study procedures. - 2
• Anticipate and mitigate risks and unplanned circumstances impacting patient qualification and data collection. - 3

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Ensure ICH GCP compliance with execution of protocols, patient enrollment and follow up, adverse event management and reporting and study activities.

• Request and initiate the purchase of materials, supplies and equipment.

• Demonstrate skills in navigating and troubleshooting a wide variety of e-clinical technologies.

• Collects research data and prepares information for inputs and analysis.

• Supports the development of forms and questionnaires.

• Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.

• Provide technical experience needed to operate the administrative functions within the clinic.

• Monitors subject's progress and reports adverse events.

• Establish relationships with non-research departments as needed for essential workflow within the clinical departments.

• Supports assembly, development and review of new research projects.

• Design recruitment and retention plans to support the study.

• Supports the creation and management of clinical websites and web-based tools.

• Work to implement the policies and procedures of the program with the clinical research team.

• Organizes and performs clinical research, utilizing internet and other available clinical resources.

• Supply study progress metrics for weekly reporting.

• Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.

• Ensure ICH GCP compliance with execution of protocols, patient enrollment and follow up, adverse event tracking and study activities.

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Design and implement quality assurance and quality-control procedures within the day-to-day research activities.

• Develops and facilitates training to new research coordinators and mentors' researchers in Good Clinical Practices.

• Monitor efficiency of procedures and contribute to the development of SOPs and internal processes to enhance the quality of study conduct.