GENERAL DESCRIPTION:

The Clinical Research Coordinator position requires knowledge and skills in clinical research coordination. This position participates in the implementation of clinical research projects (all phases), including National Institute of Health (NIH) funded AIDS Clinical Trials Groups (ACTG), state-funded, industry-sponsored, and investigator-initiated protocols.

JOB REQUIREMENTS:

• Must be able to multi-task.
• Must possess excellent interpersonal, organizational, communication and documentation skills.
• Must demonstrate an ability to work well under pressure.
• Must demonstrate the ability to keep all information confidential.
• Must be able to function autonomously and collaborate with clinicians, health team members, sponsors and patients.
• Must be proficient in Microsoft Office applications (Word, Excel).
• Familiarity with electronic data capture (EDC), clinical trial management systems (CTMS), medical terminology, and FDA regulations is highly desirable.

EDUCATION AND EXPERIENCE:

• High school diploma or G. E. D. Medical Assistant or Phlebotomy certification preferred.
• Minimum two years’ experience in clinical research or related field.
• Must have or obtain certification in Human Subjects Protections (HSP) and Good Clinical Practice (GCP) training upon hire.

SPECIFIC RESPONSIBILITIES OF THE JOB:

• Manages patient recruitment for enrolling studies. Manages screening and enrollment of participants including informed consent process, collecting and confirming inclusion and exclusion criteria, manages study participant visits and ensures all assessments and procedures are performed according to protocol requirements; administers study medication as per protocol; performs adherence counseling and investigational medication accountability, completes study visit documentation including source documents, participant questionnaires, and case report forms (CRFs); ensures that adverse events are assessed by investigator in a timely manner.
• Manages serious/expedited adverse event submissions to study sponsor and IRB and ensures these events are submitted within the sponsor’s required time frame.
• Manages adherence to study protocols as an assigned lead coordinator on one or more clinical trials.
• Performs vital signs, EKGs, phlebotomy, and may process specimen for shipment to external laboratory repositories and other related procedures as required by research trials.
• Manages regulatory documentation and submissions for assigned clinical research trials.
• Manages all aspects of the study including site feasibility, study start-up, monitoring and close-out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs).
• Serves as back up for the Laboratory Technician and data manager in their absence.
• Meets with study PIs on a weekly basis to review study participant visits and protocol updates.
• Attends bi-weekly provider meeting to provide clinical research study updates.
• Assists investigators and clinical research manager with investigator-initiated research and submissions to scientific conferences and/or publications.
• Assists clinical research manager in preparing for bi-monthly community advisory committee meetings and participating in bi-monthly meetings.
• Other duties as assigned.