HIV - Sr. Clinical Research Coordinator

Job Description - HIV - Sr. Clinical Research Coordinator )

Job Description

HIV - Sr. Clinical Research Coordinator - )

Description

The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. In addition, the individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations.

This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned.

Works under supervision of PI on the full lifecycle of clinical research studies focusing on HIV treatment and prevention. Will recruit and consent adolescents and young adults with HIV and those who may benefit from HIV and STI prevention in the community as well as outpatient and inpatient clinical settings on a weekly basis. Liaises directly with team members, PI, CNH IRB, and study-related personnel to monitor program implementation and evaluation.

Prepares documents for study progress reports, audits and regulatory filing. Maintains relevant study databases and verifies the accuracy through quality management. Coordinates study visits with internal partners and participants. Supports data initiatives for other projects as needed, identifying opportunities for improving data management. Gathers documentation and prepares performance data for sponsor assessments and audits. Participates in multidisciplinary team meetings.

B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required)

Master's Degree Master’s degree with at least 2 years of relevant experience (Required)

At least 3 years of experience with a bachelor's degree. (Required)

At least 2 years of experience with a master's degree. (Required)

• Knowledge of clinical research designs and needed infrastructure.
• Familiarity with databases, data collection tools and data analysis methods.
• Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission.
• Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.

• Internal candidates:
  Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required)
• External candidates:
  Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (Required)

• Consistently demonstrates adherence to the standards for the responsible conduct of research.
• Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
• Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects’ research and use of protected health information.
• Uses research funds and resources appropriately.
• Maintains confidentiality of data as required.
• Meets all annual job-related training and compliance requirements.

• Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
• Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report…