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. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

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
• Monitors quality metrics; prevents deviations; resolves queries quickly
• Interact in a positive, professional manner with patients, representatives, investigators and Care Access Research personnel and management
• Carefully coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives
• Mentor CRC I peers; provide onboarding and day-to-day guidance
• Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
• Moderate complexity; mixed visit types, active IP and AE/SAE workflows
• Can operate as solo CRC onsite
• Prescreen study candidates
• Obtain informed consent per Care Access Research SOP
• Complete visit procedures in accordance with protocol
• Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
• Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
• Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff
• Documentation
• Record data legibly and enter in real time on paper or e-source documents
• Accurately record study medication inventory, medication dispensation, and patient compliance
• Resolve data management queries and correct source data within sponsor provided timelines
• Assist regulatory personnel with completion and filing of regulatory documents
• Assist in the creation and review of source documents
• Patient Recruitment
• Aid in planning and creation of appropriate recruitment materials
• Aid in development of recruitment plan and obtain listing of potential candidates to contact from subject database
• Actively work with recruitment team in calling and recruiting subjects
• Review and assess protocol (including amendments) for clarity, logistical feasibility
• Ensure that all training and study requirements are met prior to trial conduct
• Communicate clearly verbally and in writing
• Anticipates needs; proposes solutions; manages change effectively
• Attend Investigator meetings as required
• Owes 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)

Requirements

• The ability to use keyboards and other computer equipment
• Walking, Standing, Sitting, Lifting (up to 25lbs and overhead), Driving - 20%

Qualifications

• 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

Skills

• 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 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
• Manages stakeholder communications; facilitates visits and meetings
• Ability to work independently in a fast-paced environment with minimal supervision

Benefits & Perks

• 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
• Relocation Support Provided

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. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

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.
• Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment.
• 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.