Care Access · 1 month ago
Clinical Research Coordinator II
Indianapolis, IN
Full-time
Onsite
Mid Level
$60K/yr - $90K/yr
3+ years expCare Access is dedicated to improving health access and outcomes through innovative clinical research and community engagement. The Clinical Research Coordinator II is responsible for ensuring compliance with Good Clinical Practices while managing clinical study subjects, coordinating patient recruitment, and maintaining documentation throughout the research process.
Clinical TrialsHealth Care
No H1B
Responsibilities
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)
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
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
Communicate clearly verbally and in writing
Prescreen study candidates
Obtain informed consent per Care Access Research SOP
Complete visit procedures in accordance with protocol
Train others and 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
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
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
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
Qualification
Required
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
A minimum of 3 years prior Clinical Research Coordinator experience required
Recent phlebotomy experience required
This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Indianapolis, IN clinic
Regularly planned travel within the region will be required as part of the role
The ability to use keyboards and other computer equipment
Preferred
Bachelor's Degree preferred, or equivalent combination of education, training and experience
Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
Bilingual in Spanish-preferred
Benefits
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
Company
Care Access
Care Access helps people learn more about their health and participate in clinical research to help find new medicines and cures.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Biomedical Advanced Research and Development Authority (BARDA)
2024-08-26Grant
Leadership Team
Ahmad Namvargolian
CEO, Co-Founder
Recent News
Company data provided by crunchbase