Reference Number: JO-2102-463337
Job Type: Permanent
Central Monitor / CRA
Location: US country-wide
Salary & Benefits: Competitive
A global CRO who have just won some fantastic new business are looking to expand their CRA talent pool across the US. They have a broad client base of pharma and medical technology clients across most therapeutic areas. They offer a highly competitive salary, benefits and bonus scheme. Benefits include unlimited PTO, 10 paid holidays and matching 401(K). They are also interested in contractors for 6 to 12-month assignments.
This role will serve as the central monitor within the assigned project team and be accountable for conducting central monitoring activities for assigned clinical trials in accordance with ICH GCP E6 requirements.
Responsibilities will include:
Understands the assigned protocol and ensures central monitoring activities are planned and executed in alignment with it and in adherence to ICH-GCP, SOPs, corporate standards and regulatory requirements.
Perform central monitoring activities including review of system outputs, identification of outliers, trends or signals and propose actions for assessment by study team. Follow-up with study teams as appropriate for action or issue resolution.
Understands the study budget for their assigned tasks.
Can provide subject matter expertise for the delivery of the centralized monitoring strategy required for the trial.
As required, develops and delivers training to the study team regarding the centralized monitoring strategy.
Ensures the documentation of the centralized monitoring strategy in the appropriate functional plan and/or development of the central monitoring plan.
Depending on experience, may contribute, along with other functional representatives, to the identification of critical data and processes and the development of the Risk Planning Tool.
Depending on experience, may contribute to the cross-functional review of risks throughout the trial.
Ensures Inspection Readiness for centralized monitoring scope.
Conducts and documents study/site level review of Key Risk Indications/Key Performance Indicators and where required, statistical monitoring and tracking of study Quality Tolerance Limits
To participate as required in sponsor meetings and audits or other third-party meetings.
Key Skills & Experience:
BSc/RN qualification and/or
At least 4 years experience in clinical research required
Prior experience of Central Monitoring and associated ICH/Regulatory guidance required
Demonstrates critical thinking skills to determine the cause and appropriate solution in the identification of issues.
Knowledge of financials linked to clinical project requirements
Demonstrated capability of working in global, matrix environment
Excellent communication, presentation and interpersonal skills
Excellent planning and organizational skills with effective time management
Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identify and mitigate potential threats to the successful conduct of a clinical research project.
Critical thinking and analytical skills to understand/analyze complex data and provide insight into risk reports, trends and outliers in data
Computer literate and numerate with a willingness to adapt to various computer systems.
Contact/How to Learn More:
To find out more information or apply, contact Sarah Goddard on 0118 959 4990 or email email@example.com
CPL Life Sciences specialises solely on the recruitment of professionals into the pharmaceutical and medical technology industries globally. We work with large, medium-sized and small pharmaceutical organisations as well as clinical research organisation and medical device companies.