How This Role Makes a Difference

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.

How You'll Make An Impact

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 research personnel
• Interact in a positive, professional manner with patients, sponsor representatives, investigators and research personnel and management
• 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)
• Prescreen study candidates
• Obtain informed consent per institutional 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

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

• 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)

The Expertise Required

• 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

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
• Recent phlebotomy experience required
• National phlebotomy certification required in certain states per regulatory requirements