Clinical Research Coordinator II (Relocation Opportunity)

About the role

The Clinical Research Coordinator II plays a crucial role in the execution of clinical research studies, adhering to Good Clinical Practices (GCP) and ensuring regulatory compliance.

Responsibilities

• Patient Coordination
• Prioritize activities with specific regard to protocol timelines
• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• Maintain effective relationships with study participants and other Care Access Research personnel
• Balances protocol needs with patient experience; proactively addresses concerns
• Maintains quality metrics; prevents deviations; resolves queries quickly
• Interacts in a positive, professional manner with patients, representatives, investigators, and Care Access Research personnel and management
• Covers pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives
• Mentors CRC I peers; provides onboarding and day-to-day guidance
• Identifies adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notifies Principal Investigator and Sponsor (where appropriate)
• Moderate complexity; mixed visit types, active IP and AE/SAE workflows
• Can operate as solo CRC onsite
• Prescreens study candidates
• Obtains informed consent per Care Access Research SOP
• Completes visit procedures in accordance with protocol
• Completes basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
• Reviews laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
• Discusses study medication, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff
• Documentation
• Records data legibly and enters in real time on paper or e-source documents
• Accurately records study medication inventory, medication dispensation, and patient compliance
• Resolves data management queries and corrects source data within sponsor provided timelines
• Assists regulatory personnel with completion and filing of regulatory documents
• Assists in the creation and review of source documents
• Patient Recruitment
• Assists with planning and creation of appropriate recruitment materials
• Assists in developing recruitment plan and obtains listing of potential candidates to contact from subject database
• Actively works with recruitment team in calling and recruiting subjects
• Review and Assess Protocol (including amendments)
• Ensures protocol clarity and logistical feasibility
• Ensures all training and study requirements are met prior to trial conduct
• Expertise Required
• Ability to understand and follow institutional SOPs
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Operates independently for most study activities; escalates complex issues as needed
• Ability to communicate and work effectively with a diverse team of professionals
• Strong organizational, prioritization, and leadership skills with a strong attention to detail
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS Word, and Excel
• Critical thinker and problem solver
• Friendly, outgoing personality; maintains a positive attitude under pressure
• High level of self-motivation and energy
• Excellent professional writing and communication skills
• Manages stakeholder communications; facilitates visits and meetings
• Ability to work independently in a fast-paced environment with minimal supervision
• Bachelor’s Degree preferred, or equivalent combination of education, training, and experience
• A minimum of 3 years prior Clinical Research Coordinator experience required
• Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
• Recent phlebotomy experience required
• Licenses:
• California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
• Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
• Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
• Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health

How We Work Together

This is an on-site position with regional commute requirements. Travel requirements vary depending on study requirements, staff needs, and company initiatives, but typically involve up to 10% travel within a 100-mile radius.

Physical demands include: The ability to use keyboards and other computer equipment. Walking - 20%, Standing - 20%, Sitting - 20%, Lifting - 20%, Up to 25lbs, Over 25lbs Overhead. Driving - 20%.

Diversity & Inclusion

We are committed to building a team that represents the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

Pay

Details on pay are not specified in the job posting.

Schedule

Details on schedule are not specified in the job posting.

Benefits

Details on benefits are not specified in the job posting.