Senior Clinical Research Associate

Role Overview

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites.
• Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations.
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely.
• Provides regular site status information to team members, trial management, and updates trial management tools.
• Completes monitoring activity documents as required by sponsor's SOPs.
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
• Escalates site and trial related issues per Sponsor's SOPs until identified issues are resolved or closed.
• Performs essential document site file reconciliation.
• Performs source document verification and query resolution.
• Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
• Verifies serious adverse event (SAE) reporting according to trial specifications and ICH GCP guidelines.
• Communicates with investigative sites.
• Updates applicable tracking systems.
• Ensures all required training is completed and documented.
• Functions with little oversight (Sr level)
• May serve as a subject matter expert for clinical operations on monitoring related activities (Sr level)
• May be assigned to complex studies and/or sites.
• Provides leadership skills to assigned projects within the clinical operations department.

Requirements

• Highly responsive and proactive, team player
• An undergraduate degree or it’s equivalent in clinical, science, or health related field from an accredited institution; a licensed health care professional (i.e. registered nurse) or equivalent work experience required.
• 2-5 years clinical monitoring experience required (CRA 2)
• 5+ years clinical monitoring experience required (Sr CRA)
• Knowledge of ICH and local regulatory authority regulations regarding drug
• Read, write and speak fluent English.
• Oncology monitoring experience required
• Experience doing feasibility/site selection/site start up required.
• Budget negotiations experience preferred.
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
• May be assigned clinical tasks where advanced negotiating skills are required.
• Located in Central or East region of the United States
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Tech Stack

• Google Cloud Platform

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways