What are the responsibilities and job description for the Clinical Research Coordinator - II position at XingImaging, LLC?
DESCRIPTION OF THE POSTION:
This is a regular, onsite full-time position in our New Haven, Connecticut facility, with the flexibility to work from home with prior approval from their direct supervisor.
The Clinical Research Coordinator (CRC) will oversee the execution of research studies according to established study protocols. Responsibilities include study start-up, screening, eligibility determination, registration, and tracking various protocol and subject milestones. The CRC will have direct contact with research participants, manage multiple clinical research projects/trials, and serve as a backup to other clinical research coordinators within the team.
MAJOR AREAS OF RESPONSIBILITY:
• Administers neuropsychological tests with participants and caregivers.
• Manages internal and external communications with senior level employees, vendors, sponsors, study team members, participants, and study monitors.
• Manages delegated responsibilities of the day-to-day activities associated with the implementation and conduct of moderately to highly complex clinical studies and serves as the primary contact for the research participants.
• Manages the informed consent process with the participant and/or caregiver and addresses any questions or concerns.
• Identifies occurrences of noncompliance and deviations from protocol and advises and reports these to the appropriate parties.
• Acquires all protocol driven data points including but not limited to medical history, medications, height and weight measurements, vital signs, and ECGs for moderately to highly complex clinical studies.
• Collects, processes, and prepares for shipment study specimens and/or supports licensed staff with procedures like lumbar punctures and skin biopsies for moderately to highly complex clinical studies.
• Organizes scheduling and travel for participant visits.
• Creates and manages source documentation and supplemental study materials.
• Manage study recruitment and updates study tracking systems and logs.
• Oversees and performs data entry and query management.
• Actively participates in meetings and teleconferences with other research colleagues by organizing and presenting study status updates, sharing best practices, and troubleshooting challenges.
• Train junior clinical research team members in the Clinical Research Coordinator I role.
• Other duties as assigned by the Clinic Director.
QUALIFICATIONS AND REQUIREMENTS:
Required:
• Bachelor’s degree in science or health related field &/or minimum 3-5 years equivalent experience in a related healthcare position, or equivalent relevant experience
• Demonstrated advanced knowledge of Good Clinical Practices and Good Documentation Practices
• Ability to work independently with minimal supervision but also collaboratively with clinic study team staff
• Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality
• Strong analytical, communication, and organizational skills with a high attention to detail
• Proven knowledge of medical terminology, clinical medicine, clinical trial protocols, and internal SOPs
• Proven problem-solving, critical decision makings and professional judgement
• Embodies ethics and integrity in all work, respecting both company and broader community policies in all conduct
• Strong commitment to the team; maintains positive working relationships with diverse people, including internal team and external partners
• BLS certification
Unique Department Requirements:
• Exposure to ionizing radiation
• Biohazard exposure to human blood and bodily fluids
• Ability to lift and move up to 50 lbs (for heavy equipment and patient positioning)
• Intermittent evening and weekend work may be required
• Travel to meetings may be required
PLEASE NOTE:
Please note that since this is position is at least partially onsite, in the case of epidemic or other health crisis, employee must be willing to take reasonable steps to ensure that bacterial and viral infections are not spread to others including but not limited to temperature checks, vaccinations, exclusion from the office building, and other precautions as required by the building’s landlord.