Clinical Research Coordinator II (Indianapolis, IN) Job at Care Access in Indian

Clinical Research Coordinator II (Indianapolis, IN)

Overview

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 into 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. Through programs like Future of Medicine and Difference Makers, we put people at the heart of medical progress. To learn more about Care Access, visit www.CareAccess.com.

How This Role Makes a Difference

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCPs) in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

How You'll Make An Impact

• Duties include but not limited to:
• Ability to understand and follow institutional SOPs.
• Review and assess protocol (including amendments) for clarity, logistical feasibility.
• Ensure that all training and study requirements are met prior to trial conduct.
• Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
• Assist with planning and creation of appropriate recruitment materials.
• Assist 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.
• Attend Investigator meetings as required.
• Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
• Assist in the creation and review of source documents.
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).
• Study Management: Prioritize activities with specific regard to protocol timelines and maintain adherence to FDA regulations and ICH guidelines.
• Maintain effective relationships with study participants and other Care Access Research personnel.
• Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
• Communicate clearly verbally and in writing.
• Patient Coordination: Prescreen study candidates; obtain informed consent per SOP; complete visit procedures; train others and complete basic clinical procedures (blood draws, vital signs, ECGs, etc.); review laboratory results and ensure timely investigator review; identify adverse events and notify PI and Sponsor as appropriate.
• Documentation: Record data legibly and in real time; manage study medication inventory and patient compliance; resolve data management queries; assist regulatory personnel with regulatory document filing.
• Perform other duties as assigned. The duties listed are representative and not all-inclusive.

Expertise Required

• Excellent working knowledge of medical and research terminology.
• Excellent working knowledge of federal regulations and good clinical practices (GCP).
• Ability to communicate and work effectively with a diverse team of professionals.
• Strong organizational, prioritization and leadership skills with attention to detail.
• Strong computer skills with experience using clinical trials databases, 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.

Certifications/Licenses, Education, And Experience

• Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
• A minimum of 3 years prior Clinical Research Coordinator experience required.
• Prior Care Access Research experience is a plus.
• Recent phlebotomy experience required.
• Bilingual in Spanish preferred.

How We Work Together

• Location: This is an on-site position with regional commute requirements. Onsite work 5 days per week at the Indianapolis, IN clinic.
• Travel: Regularly planned travel within the region will be required.
• Physical demands: Ability to use keyboards and other computer equipment.

Benefits & Perks

• PTO and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance 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 when we build a team representing the communities we support, and we maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

Care Access is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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. Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Research Services