Sr Clinical Research Coord

About the role

This job evaluates, initiates, and manages all activities related to the conduct of clinical trials. It involves communicating with external funding agencies and sponsors, other departments, and patients to ensure understanding of the requirements of conducting and participating in clinical trials. The role also involves organizing and managing patient care requirements, serving as an escalation point for junior level departmental staff, and coordinating the most complex and numerous trials.

Responsibilities

• Evaluates competing strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings and coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI).
• Serves as primary point of contact for patient to report and triage adverse events and serves as a mentor to staff on obtaining informed consent.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Performs clinical laboratory activities as required per protocol and maintains study supplies and equipment.
• Maintains close communication with study sponsor representatives including but not limited to site initiation, maintenance, and close out of studies.
• Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
• Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems.
• Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
• Provides mentorship, professional development, and support to less senior team members and interns; assesses quality assurance of study visits and data; periodically reviews and provides constructive feedback on standard operating procedures; and coordinates special projects related to workflow optimization.
• Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style.
• Performs other related duties as assigned.

Requirements

Required - High school diploma or equivalent.

Required - 5 years of relevant research experience in a clinical setting, OR 4 years of relevant research experience in a clinical setting with Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) certification.

Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.

Qualifications

• Knowledge of medical and clinical research terminology and processes.
• Expert understanding of ICH guidelines for ethical conduct of research.
• Familiarity with and understanding of lean management principles.
• Ability to follow and provide critical feedback on the investigational plan.
• Ability to develop study related budgets, contracts, and patient consent documents.
• Ability to mentor junior staff members on the requirements and regulations associated with the conduct of clinical trials and other related research activity.
• Expertise in using computers and web-based applications including working knowledge of Epic (Super-Users).
• Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
• Strong interpersonal and leadership skills and ability to coach others, as well as effectively work independently.
• Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and develop new techniques.
• Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts.