Clinical Research Coordinator I (Yonkers, NY)

Care Access • Yonkers, NY

115d

About The Position

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

Requirements

• 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).
• 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.

Nice To Haves

• Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
• A minimum of 1-year prior Clinical Research Coordinator experience required.
• Recent phlebotomy experience required.

Responsibilities

• 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.
• Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
• Prioritize activities with specific regard to protocol timelines
• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
• Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
• 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.
• Assist in the creation and review of source documents.
• 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.
• 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.
• Attend Investigator meetings as required.
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).
• Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
• Maintain effective relationships with study participants and other Care Access Research personnel.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree