Clinical Monitoring Associate (REMOTE)

The Clinical Monitoring Associate Functional Services shall involve:

Principal Responsibilities:

• Learn and assimilate knowledge about clinical trial procedures and operations, Good Clinical Practices, and regulatory requirements.
• Support the team in basic administrative tasks and documentation, under supervision.
• Participates in site feasibility and/or pre-trial site assessment visits, providing input on site/investigator selection in collaboration with the trial team, under supervision. 
• Attends investigator meetings as needed for observational purposes.
• Supports activities related to site initiation and start-up, site monitoring, site management and site-study close-out according to internal and client SOPs, working practices, working Instructions, guidelines, applicable regulations, and the principles of ICH-GCP, under supervision.
• Supports local project planning activities in conjunction with the primary Clinical Research Associate to meet recruitment targets and to deliver high quality data on time and per the monitoring plan requirements.
• Supports site staff training activities and accurate filing of documentation of training, under supervision.
• Confirms site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct, under supervision.
• Confirms that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented. Arranges for appropriate destruction of clinical supplies, under close supervision.
• All Serious Adverse Events/Product Quality Complaints are to be reported within reporting timelines and documented as appropriate. The CMA will also ensure that they are consistent with all data collected and with the information in the source document under close supervision of the primary site CRA.
• Under close supervision, confirms site staff completes data entry and resolves queries within the expected timelines.
• Under close supervision, confirms accuracy, validity and completeness of data collected at trial sites
• Under close supervision, participates in the full documentation of trial related activities, in particular monitoring- confirmation letters/visit reports/follow-up letters and the upload into eTMF.; Assist in organizing and maintaining study documentation, understanding the importance of accurate record-keeping.
• Under close supervision, promptly communicates relevant issues and status information to appropriate trial team members.
• Complies with relevant training requirements to learn about compliance, safety reporting, monitoring skills, therapeutic area, sponsor processes and regulatory requirements to conduct a trial.
• Develops an understanding of the various stakeholders.
• Engage in team meetings, contribute ideas, and gain exposure to cross-functional collaboration within the work environment.
• Observe monitoring activities (site selection, site initiation, on-site monitoring, remote monitoring, and close-out visits) learning how to conduct these types of visits, interact with site personnel and document observations.
• Maintain patient, Organization confidentiality.

Education:

• New college graduate, graduating no more than 12 months prior to their start date, with a Bachelor’s or Master’s degree (e.g., BS, MS), in Sciences/Health Sciences or related field.
• GPA 3.0 minimum