
Clinical Operations Specialist
14 hours ago
We are seeking a Senior Clinical Research Associate II to join our team. As a key member of our clinical operations group, you will be responsible for monitoring clinical research studies to ensure compliance with widely accepted clinical practices.
This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. You will work closely with cross-functional teams to ensure successful trial execution, including project managers, data managers, biostatisticians, and regulatory affairs specialists.
Key Responsibilities:
- Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, 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
- Identify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and preventive actions as needed
- Bachelor's degree in a related field, preferably in a life science or a scientific discipline
- Minimum of 5 years of experience in clinical research monitoring, preferably at the P22 level
- In-depth knowledge of clinical trial processes and regulations
- Strong analytical and problem-solving skills, with ability to prioritize tasks effectively
- Excellent communication and interpersonal skills, with ability to build strong relationships with colleagues and stakeholders
- Ability to work independently and as part of a team, with flexibility to adapt to changing priorities and deadlines
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