Clinical Research Coordinator II

About the role

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

Responsibilities

• Utilize Good Clinical Practices (GCP) in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
• Duties include but not limited to:
• Understanding and following institutional SOPs.
• Reviewing and assessing protocol (including amendments) for clarity, logistical feasibility.
• Ensuring that all training and study requirements are met prior to trial conduct.
• Discussing study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
• Aiding in the planning and creation of appropriate recruitment materials.
• Aiding in the development of recruitment plans and obtaining a listing of potential candidates to contact from the subject database.
• Actively working with the recruitment team in calling and recruiting subjects.
• Attending Investigator meetings as required.
• Coordinating and attending pre-study site visits, site initiation visits, and monitoring visits with clinical staff and Sponsor/CRO representatives.
• Aiding in the creation and review of source documents.
• Ensuring adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).
• Study Management
• Prioritizing activities with specific regard to protocol timelines.
• Maintaining adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
• Maintaining effective relationships with study participants and other Care Access Research personnel.
• Interacting in a positive, professional manner with patients, sponsor representatives, investigators, and Care Access Research personnel and management.
• Communicating clearly verbally and in writing.
• Patient Coordination
• Prescreening study candidates.
• Obtaining informed consent per Care Access Research SOP.
• Completing visit procedures in accordance with protocol.
• Training others and completing basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
• Reviewing laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
• Identifying adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notifying Principal Investigator and Sponsor (where appropriate).
• Documentation
• Recording data legibly and entering in real time on paper or e-source documents.
• Accurately recording study medication inventory, medication dispensation, and patient compliance.
• Resolving data management queries and correcting source data within sponsor-provided timelines.
• Aiding regulatory personnel in the completion and filing of regulatory documents.
• Performing other duties as assigned.

Qualifications

• Excellent working knowledge of medical and research terminology.
• Excellent working knowledge of federal regulations, good clinical practices (GCP).
• Ability to communicate and work effectively with a diverse team of professionals.
• Strong organizational, prioritization and leadership skills and capabilities 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; maintain a positive attitude under pressure.
• High level of self-motivation and energy.
• Excellent professional writing and communication skills.
• Ability to work independently in a fast-paced environment with minimal supervision.
• 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.
• Bilingual in Spanish preferred.

Benefits & Perks

The expected pay range for this role is $60,000 - $90,000 USD per year for full-time team members.

Benefits & Perks (US Full Time Employees)

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer-paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company-paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match

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.

Notice to Applicants

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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