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Senior Clinical Research Monitor
2 weeks ago
Clinical Research Associate II Position Summary: We are seeking a Clinical Research Associate II to join our team. The successful candidate will be responsible for monitoring clinical research studies to ensure compliance with widely accepted clinical practices.
">- 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
- Collaborate with cross-functional teams to ensure successful trial execution, including working with project managers, data managers, biostatisticians, and regulatory affairs specialists
Required Skills and Qualifications:
- Bachelor's degree in a related field
- Minimum of 5 years of experience in clinical research monitoring; this role is a progression within the level from a Sr CRA I
- In-depth knowledge of clinical trial processes and regulations
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
Benefits:
- Passionate about developing people through career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Committed to Total Self culture - where you can authentically be yourself
Other Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities at its sole discretion.
Core Focus- Ensure regulatory, ICH-GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close-out visits
- Evaluate overall performance of site and site staff, provide recommendations regarding site-specific actions, and communicate serious issues to the project team
- Verify the process of obtaining informed consent, protect the confidentiality of subjects/patients, and assess factors affecting subject/patient safety and clinical data integrity
- Conduct Source Document Review, verify clinical data accuracy and completeness, and apply query resolution techniques
- Verify site compliance with electronic data capture requirements and investigational product (IP) inventory, reconciliation, storage, and security
- Review Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile contents with the Trial Master File (TMF)
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met
- Act as primary liaison with study site personnel, ensure training and compliance with applicable requirements, and provide guidance towards audit readiness standards
- Provide direct supervision, training, and mentorship to junior level CRAs
