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.