Transforming clinical research by ensuring compliance with globally accepted practices is a key responsibility of this role. Conduct on-site and remote monitoring of clinical studies to guarantee adherence to protocol, case report forms, and regulatory documents.
Develop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating procedures.
Contribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stages.
Direct the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activities.
Ensure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that arise.
Provide guidance and support to clinical research teams, including answering questions, resolving issues, and facilitating communication between team members and stakeholders.
Maintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databases.
Qualifications
* Bachelor's degree in a related field
* Minimum of 5 years of experience in clinical research monitoring
* In-depth knowledge of clinical trial processes and regulations
* Strong analytical and problem-solving skills
* Excellent communication and interpersonal skills
Certifications:
* Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Necessary Skills:
* Proficiency in clinical trial management systems and software
* Ability to manage multiple projects and priorities
* Strong attention to detail and organizational skills
* Ability to travel as required for on-site monitoring
* Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
Benefits
* Opportunity to work with a leading biopharmaceutical solutions organization
* Chance to contribute to the success of clinical research studies
* Competitive compensation and benefits package
* Professional growth and development opportunities
* Collaborative and dynamic work environment
Others
* Summary: This role involves individual contributors with responsibility in a professional or technical discipline or specialty, who may manage two or fewer employees and direct the work of lower-level professionals or manage processes and programs.
* Impact and Contribution: Roles within Clinical Monitoring/CRA job family at the P22 level have a significant impact on the success of clinical research studies.