This highly motivated candidate will perform study site management start-up activities to include site selection and assisting sites with preparing IRB submission documents. Responsibilities will include
developing and maintaining professional working relationships with clinical investigative sites, as well as serving as primary contact with frequent communication with site personnel.
Conducts Site Initiation Visits that include protocol specific training to ensure that Principal Investigator and site personnel understand the protocol requirements, study conduct and activities, and adherence to regulatory guidelines and SOPs
Conducts Interim Monitor Visits to ensure that sites meet performance expectations and are adhering to protocol requirements, study conduct and activities, and adherence to regulatory guidelines and SOPs
Conducts Close Out Visits to include reconciliation of study documents and discussion of post-study responsibilities with Principal Investigator and Site personnel
Strong written and verbal communication skills are required. Succinctly reports significant deviations, discrepancies with study data, and other significant issues noted during monitoring visits in the monitor reports; escalate issues to the appropriate Company personnel, as needed
Prepares and submits monitoring reports, confirmation and follow up letters, and telephone contact reports in a timely, concise, and objective manner per the Monitoring Plan
Ability to work in a fast-paced, dynamic environment with a committed team
Clinical Trial Associate Consultant (Part-time)
20-30 hours per week. Onsite 3 to 4 days/week
Developing study logs and documents for study start-up
Compiling TMF for upcoming trial
Preparing documents for IRB submission
Creating and distributing regulatory binders to sites
Communicating with sites to obtain regulatory documents for site start-up
Track progress of site start-up activities and documents.
Bachelor's degree preferably in science or health-related field (nursing, medical technology, or pharmacy) or Associate’s degree combined with relevant clinical experience.
Four or more years of clinical research related experience and/or training
Extensive experience monitoring clinical sites conducting drug and/or device trials
Extensive experience in management of clinical trial sites
Frequent travel estimated at 50%
Two plus years of clinical trial experience. Experience in pharmaceutical industry/CRO