Clinical Research Coordinator I, Neurosurgery

Clinical Study Coordination:

• Coordinate and perform day to day operational and administrative activities in support of the research projects.
• Screen, consent and register participants to clinical studies.
• Schedule participant appointments and procedures.
• Collect data for the clinical studies (surveys, EKG, vitals).
• Ensure data is accurate and submitted into appropriate data management systems.
• Conduct routine study-required clinical support tasks such as specimen handling, basic Adverse Event (AE) documentation with escalation.
• Complete sponsor mandated trainings.
• Participate in Site Evaluation Visits (SEV), Site Initiation Visits (SIV), monitoring visits and close out visits for Investigator Initiated trials, and sponsored studies.

Communication:

• Maintain appropriate communication between clinic staff, research staff, study monitors, physicians and patients.
• Attend weekly meetings to discuss project progress.
• Interact with patient/subject and families in a courteous and professional manner.
• Be consistent and regularly follow through with patients/subjects reminding them of visits and appointments.

Regulatory compliance:

• Under the direction of the Principal Investigator (PI), supervisor and/or higher-level research staff, aid in IRB submissions and amendments new or revised protocols.
• Comply with all regulatory agency requirements and protocol guidelines.
• Protect subject confidentiality by ensuring compliance with storage of data, release of information, and disposal of records.

Other:

• Perform work with basic knowledge and operation of University systems and department tools.
• Provide support for higher-level research staff members.
• Receive direction and guidance from supervisor to perform work.

Knowledge, Skills & Abilities:

• Skill in time management, organization, and prioritization of tasks.
• Excellent written and verbal communication skills.
• Ability to maintain a professional demeanor in workplace interactions
• Ability to conduct research in accordance with established quality standards and regulatory requirements.