Clinical Research Coordinator II

About the role

The Clinical Research Coordinator II utilizes Good Clinical Practices (GCP) in the process of screening, enrolling, and closely monitoring clinical research study subjects while ensuring protocol and 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)
• Moderates 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

• Reviews and assesses protocol (including amendments) for clarity, logistical feasibility
• Ensures that all training and study requirements are met prior to trial conduct
• Communicates clearly verbally and in writing
• Anticipates needs; proposes solutions; manages change effectively
• Attends Investigator meetings as required
• Owns studies; prioritizes competing demands; mentors CRC I
• Ensures adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)

The 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

The Expertise Required (continued)

• Minimum Education: Bachelor’s Degree preferred, or equivalent combination of education, training and experience
• Minimum Experience: 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

How We Work Together

• Location: On-site position with regional commute requirements
• Travel: Up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.
• Type of travel required: Regional (within 100 miles)

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing 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.

Mandatory Employer Disclosures

• Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
• Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
• Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
• Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
• Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
• Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.

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