CRC neurosciences on site

About the Role

This position evaluates, initiates, and maintains all activities related to the conduct of clinical trials. You will communicate with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure understanding of the requirements for conducting and participating in clinical trials. The role involves organizing and managing all patient care requirements and coordinating trials that are more complex and/or involve a greater number of trials than the associate level.

Responsibilities

• Organizes strategies for recruiting study participants and screening them for eligibility via telephone, clinic visits, and other settings.
• Coordinates and oversees patient (study participant) activity related to research and clinical trials, serving as a liaison for both patients and the Principal Investigator (PI).
• Serves as the primary point of contact for patients to report and triage adverse events and independently conducts 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 site initiation, maintenance, and close-out of studies.
• Develops and maintains all required documentation related to assigned clinical trials and associated patient care.
• Completes data entry into sponsor-specific systems, supports data coordination, resolves queries, and transcribes information across internal and external electronic systems.
• Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
• Adapts behavior to specific patient populations, including respect for privacy, communication style, and explanation of services or procedures.
• Performs other related duties as assigned.
• Remains knowledgeable on current federal, state, and local laws, accreditation standards, or regulatory requirements applicable to the assigned area and ensures compliance.

Requirements

• High school diploma or equivalent (required).
• 3 years of relevant research experience in a clinical setting, OR 2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification.
• Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire (exceptions for fully remote status).

Skills

• Knowledge of medical and clinical research terminology and processes.
• Working knowledge of ICH guidelines for ethical conduct of research.
• Strong critical thinking skills and ability to follow/provide feedback on investigational plans.
• Ability to develop study-related budgets, contracts, and patient consent documents.
• Working knowledge of requirements and regulations for conducting clinical trials and related research.
• Proficiency in using computers, software, and web-based applications, including Epic.
• Effective verbal and written communication skills; ability to present information clearly to varying audiences.
• Strong organizational and time management skills; ability to multitask and pay close attention to detail.
• Ability to travel throughout and between facilities and work a flexible schedule, including on-call, weekends, and night shifts.

Physical and Environmental Demands

• Medium Work: Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds frequently, and/or negligible to 10 pounds constantly to move objects.
• Duties performed routinely require exposure to blood, body fluids, and tissue.
• Works in patient care areas, directly with patients, and/or with specimens that may contain communicable diseases.
• Occupational risk for exposure to hazardous medications or hazardous waste through handling, transport, storage, preparation, dispensing, administration, cleaning, or disposal.