Do you want to improve your work life balance and be appreciated? We are a team that is passionate about clinical research and making a difference in our community. Join a privately held, growing CRO whose core values include a commitment to the personal growth of our employees. Be a part of a company with expertise in conducting trials that benefit the lives of critically and chronically ill patients.
Completes project activities associated with monitoring functions of Phase I through Phase IV clinical research studies while continuing to develop knowledge of drug development process, ICH / Good Clinical Practice (GCP), and applicable local regulations. Provides clinical and technical support for Clinical Research Associates (CRAs) and administrative staff. Performs management of study site activities to ensure integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
Duties and Responsibilities
Serves as main CTI contact for assigned investigative sites.
Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Study Manager / sponsor.
Creates and implements subject enrollment strategies for assigned investigative sites.
Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan.
Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.
Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product.
Completes in-house monitoring activities as appropriate, such as updating in-house site files, conducting remote monitoring for electronic data capture (EDC) studies, and completing visit reports / letters.
Anticipates / identifies site issues and implements corrective actions or escalates to Study Manager / sponsor as necessary.
Participates in development of CRFs and other study related documents (source documents, subject worksheets, Monitoring Plan, etc).
Conducts / oversees project-specific administrative activities as member of Project Team.
Assists in preparation and coordination of Project Investigator (PI) meetings and attends / presents at Investigator meetings as necessary.
Attends sponsor meetings as necessary.
Participates in capabilities presentations as necessary.
Participates in feasibility activities and reports outcome to appropriate CTI personnel.
Serves as mentor / trainer for CRAs including in-house and on-site training.
Participates in the interview process for CRA candidates.
Reviews protocols and provides feedback to Study Manager.
Works with Study Manager to create Project-Specific Operating Procedures (PSOPs) as necessary.
Represents CTI in professional manner.
Coordinates with and provides information to new business development regarding any potential new business opportunities.
Continues to increase knowledge of drug development process, therapeutic areas, ICH / GCP, and any applicable local regulatory requirements.
Accurately completes CTI administrative activities in timely manner.
Minimum of 3 years of clinical trial monitoring experience.
Demonstrated successful performance of CRA-level position with minimum of 3 to 4 years monitoring experience, including transplant or in-patient monitoring experience.
Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company, or CRO is preferred.
Experience or education providing sound basic knowledge of medical and pharmaceutical terminology.
Bachelor’s or Master’s Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or
RN with Associate’s Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience, or
Equivalent experience as determined by CTI Management and Human Resources.