Clinical Operations Manager Must be a Licensed Therapist or Masters Level Psychiatric Nurse

Company Overview Be part of a team working to research cutting edge, new and innovative treatments in an outpatient setting! Instead of impacting one patient's life at a time, research allows you to work with new, cutting-edge medications that can affect the lives of millions. This office is fast-paced and 100% research dedicated. It has a clear history of outstanding work. Highly competitive compensation package including medical, dental and 401K. No weekends. No nights.

Hours of operation:

M-F, 8am - 5pm. Job Overview We are seeking an experienced and motivated clinical research professional to provide leadership and support to clinical personnel in the performance and conduct of clinical trials in alignment with the mission and values of CNS Healthcare research sites. The ideal candidate will promote and uphold Good Clinical Practice (GCP) standards through extensive knowledge of FDA regulations, ICH guidelines, sponsor requirements, and site procedures related to the enrollment, management, and retention of study participants. This role is responsible for supporting the successful execution of clinical investigations by ensuring accurate collection, documentation, and maintenance of source and sponsor-related records while maintaining protocol compliance, participant safety, data integrity, and overall study quality throughout all phases of the clinical trial process. Primary Responsibilities Trial Management CRC Team Management Rater/Psychedelic Therapist Clinical Operations Management Project Management/QA Support Education & Training Support Achieve Visit Volume Goals Sponsor Relations Physician (PI) Relations Supports Strategic Planning with

Leadership Team Qualifications More Specific Responsibilities:

Thorough adaptation to assigned studies through reading protocols, attending investigator meetings and start-up meetings, and orienting with Principal Investigator and Sub-Investigators. Collect initial psychiatric and medical information by interviewing patients and by accessingother appropriate sources. Serve as DSM/rater on assigned trials. Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging. Dispense and maintain accurate records of study medication. Ensure that EDC is entered timely with minimal compliance issues. Regular communication of protocol issues to CRO and/or sponsor, site administrator/site director; strictly adhere to the study protocol, obtaining exemptions when necessary/ appropriate. Assist coordinators with assigned tasks as necessary. Problem solve protocol issues with staff as necessary. Support and assist with protocol adherence as necessary. Ensure that clinic is staffed and the team is trained sufficiently to meet visit volume goals on a monthly basis. Ensure adequate coverage in the clinic to ensure a smooth flow of patients throughout the day. Communicate protocol issues to CRO and/or sponsor, site administrator/clinical director. Ensure flow of communication, including telephone conferences, between patient, study staff, referral sources, sponsor and/or CRO, monitor(s), auditors and any marketing groups hired by the sponsor. In conjunction with Site Administrator, guides orientation of all new clinical employees. In conjunction with Site Administrator, develop training plans to meet the needs of each individual. Support staff development with ongoing QA of clinical team members and trials in real time to address and identify any training needs they may have. Support quality oversight by performing audits and trial reviews and working with Site Administrator to develop correction plans when needed. Oversee the timely, accurate start up of all studies in the clinic. Assist in the assignment of coordinators/raters/other staff to trials. Assist in meeting enrollment goals. Other duties as assigned. Qualifications Prefer at least 2 years of work-related experience in Clinical Research MSN or Licensed therapist credentials at a minimum are required Knowledge of FDA, GCP and ICH guidelines and regulations Ability to meet the demands of numerous Sponsors, CROs and IRBs Join us at CNS Healthcare to be part of a forward-thinking team committed to transforming healthcare through innovative research. We value energetic professionals who are passionate about making a difference in patient care while developing their careers in a supportive environment.

Benefits:

401(k) Dental insurance Health insurance Paid time off

Work Location:

In person