GENERAL DESCRIPTION:

The Senior Clinical Research Coordinator position requires advanced knowledge and skills in clinical research coordination and ensures compliant execution of all study-related activities in compliance with all federal, state and local regulations. This position is responsible for implementation and daily operations of clinical research trials (all phases) sponsored by the National Institute of Health (NIH) funded AIDS Clinical Trials Groups (ACTG), and/or private pharmaceutical industry as well as investigator-initiated protocols.

JOB REQUIREMENTS:

• Must be able to multi-task.
• Must be detail oriented.
• Must possess critical thinking skills.
• Must possess excellent interpersonal, organizational, communication and documentation skills.
• Must demonstrate an ability to be flexible and work well under pressure.
• Must demonstrate the ability to keep all information confidential.
• Must be able to function autonomously and collaborate with patients, clinicians, health team members, sponsors, IRBs, IBCs and CROs.
• Must be proficient in Microsoft Office applications (Word, Excel).
• Must be proficient in obtaining vital signs, performing EKG, phlebotomy, and laboratory specimen processing/shipping.
• Familiarity with electronic data capture (EDC), clinical trial management systems (CTMS), medical terminology, and FDA regulations is highly desirable.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in public health, science or related field or appropriate combination of education and experience with at least 3 years of experience as a clinical research coordinator.
• Must have or obtain certification in Human Subjects Protections (HSP) and Good Clinical Practice (GCP) training upon hire.
• Certification by Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.

SPECIFIC RESPONSIBILITIES OF THE JOB:

• Under the direction of the Clinical Research Principal Investigator (Pl) and the Clinical Research Manager, responsible for managing the daily conduct of the organization’s clinical research trials ensuring adherence to clinical research protocols, good clinical practice (GCP), human subject protections (HSP) and standard operating procedures (SOPs).
• Manage all aspects of the clinical research trial including regulatory submissions, study start-up activities, participant recruitment, screening, enrollment, follow-up and retention as well as quality management and close-out activities.
• Create and update all study-specific source documents to accurately collect and document protocol defined data points.
• Create, implement and manage protocol-specific recruitment plan to ensure efficient screening and enrollment of eligible participants. Review providers’ schedules to identify potential research participants. Attend bi-monthly provider meetings to inform providers of enrolling clinical trials and request referrals of patients. Email local providers to inform them of enrolling clinical trials.
• Manage participant screening activities including performing and documenting informed consent process with study investigators in accordance with ICH and FDA guidelines.
• Perform screening procedures (obtaining vital signs, review of medical history, medication history, performing EKG, ensuring lab specimens are collected, questionnaires, etc.) according to study protocol to determine if the potential participant is eligible for study participation.
• Review and analyze screening results (labs, EKG, medical medication history, etc.) with study Pl to confirm eligibility for study participation. This includes thoroughly reviewing the patient’s medical history via the EMR for any exclusionary medical conditions or medications.
• Once a patient is enrolled, manage all patient’s research study visits and ensures all procedures, assessments and evaluations 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.
• Complete and maintain all research required training certificates (Good Clinical Practice, Human Subject Protection, and Shipping of Dangerous Goods).
• Complete cross-training for protocol-specific laboratory requirements in order to provide back-up coverage to collect, process, and ship laboratory specimens in lab technician’s absence.
• Complete cross-training for protocol-specific data management activities in order to provide back-up coverage to enter study visit data and resolve queries in the data manager’s absence.
• Complete cross-training for all protocols to provide back-up coverage to other study coordinators in their absence.
• Meet with study Pis on a weekly basis to review study participant visits and protocol updates.
• Manage investigator-initiated research submissions to scientific conferences and/or publications.
• Assist investigators with preparation and submission of abstracts for publication at medical and research conferences. If accepted, assist investigators with preparation of presentation. Attend conference as invited presenter of oral or poster presentation.
• Assist clinical research manager in preparing for bi-monthly community advisory committee meetings and participating in bi-monthly meetings.
• Assist clinical research manager with preparation of monthly financial reporting.
• Other duties as assigned.