Senior Clinical Research Associate
Role and Responsibilities
- Participates in the design, planning and implementation of the overall strategies and plans of clinical research projects
- Obtains and reviews all required essential documents necessary for study/site start up and initiation
- Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol and company SOPs
- Maintains accurate and timely sponsor/site correspondence and communication
- Manage and organize internal team meetings, investigator meetings, and other trial specific meetings, as requested
- Prepares and presents project progress reports
- Supports and may lead (under supervision) the development and review of clinical study plans, presentations or study-related documents
- Assist in the development and design of CRFs, including participating in the EDC and IRT specification process and UAT
- Assists with set-up of third party study vendors and CROs as required, including liaising with Project/Program Manager to ensure site training and timely initiation
- Assists with providing oversight of CROs and vendors including managing cross-functional teams
- Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Project/Program Manager, as needed
- Maintains oversight of CRO clinical monitoring activities and the overall site management ensuring compliance with project-specific plans, Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
- May perform quality control site visits of CRO CRAs assigned sites to ensure compliance with project-specific plans, SOPs and general GCP compliance
- May conduct independent site evaluation, initiation, interim or close-out monitoring visits as required
- Tracks and reviews monitoring trip reports and tracks resolution of action items
- Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
- Manage, mentor, and provide oversight for junior team members
- Collaborates with internal cross-functional teams working in a matrix environment to ensure effective delivery of the assigned project milestones
- Provides support in the development and management of scope of work (SOW) for third party vendors per contract including quality, budget, and detailed timelines for investigator and vendor payments, as applicable
- Support Quality Assurance and regulatory authority inspection audits
- Recommends and implements innovative ideas to increase efficiency and quality of project/program/department management activities
- Works on problems of a diverse and complex scope where analysis of information requires evaluation of identifiable factors
- Must demonstrate good judgment in selecting methods and techniques for obtaining solutions
- Receives little instruction on day-to-day activities and general instructions on new assignments
Qualifications and Education Requirements
- Bachelor’s degree or equivalent experience required
- Minimum 2 years clinical trial monitoring and/or management experience in the pharmaceutical or biotech
- Minimum 1 year experience as a CRA supporting an oncology clinical trial or other relevant indication
- Demonstrates core understanding of medical terminology and clinical trial planning and conduct activities
- Thorough understanding of FDA regulations and ICH GCP guidelines
- Understanding of clinical trial processes from study start-up through study closure
- Ability and willingness to travel 10-20%
- Excellent teamwork and collaboration skills
- Proficient with Microsoft Office.
- Able to build effective working relationships throughout the organization internally and externally to achieve goals.
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, transparency, and drive.
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