(Senior) Clinical Research Associate

TFS HealthScience

6d

About The Position

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. The (Senior) Clinical Research Associate (CRA) will function operationally as a member of a Project Team and is responsible for the initiation, on–site and/or remote monitoring, close out of study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other regulatory requirements. As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

Requirements

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• Must have at least 3 years of oncology monitoring experience, including a minimum of 1 year in Phase I/II oncology studies.
• Strong GCP/ICH knowledge.
• Fluency in English.
• Able to work in a fast-paced environment with changing priorities.
• Ability to work independently as well as in a team matrix organization.
• Strong written and verbal communication skills.
• Excellent organizational skills
• Technology savvy and good software and computer skills
• Soft skills: Self-awareness, resolute, flexibility, proactivity, collaborative mindset, analytic approach, and attention to detail

Responsibilities

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.
• Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy.
• Verify proper management and accountability of Investigational Product.
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
• Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
• Timely delivering site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
• Participate in audit and/or inspection, its preparation and follow-up activities, as needed.
• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
• Update CTMS and all other required by projects systems with accurate site level information

Benefits

• opportunities for personal and professional growth in a rewarding environment
• join a team that values collaboration, quality, and making a difference in the lives of patients

What This Job Offers

• Job Type: Full-time
• Career Level: Senior