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Senior Clinical Research Associate
hace 2 meses
We are seeking a highly skilled Senior Clinical Research Associate to join our team at CTI Clinical Trial Services, Inc. As a Senior Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by providing high-quality site management and monitoring services.
Key Responsibilities- Serve as the primary point of contact for assigned study sites, ensuring seamless communication and collaboration.
- Conduct site visits, including pre-study, site initiation, interim monitoring, and close-out visits, to ensure compliance with regulatory requirements and study protocols.
- Assist with study start-up activities, including feasibility, pre-study activities, and site selection, to ensure timely and efficient trial execution.
- Collect, review, and track essential and regulatory documents to ensure compliance and accuracy.
- Participate in investigator, client, and project team meetings, including presentations, to ensure effective communication and collaboration.
- Develop and implement subject enrollment strategies for assigned study sites to ensure timely and efficient trial execution.
- Ensure proper storage, dispensation, and accountability of Investigational Product (IP) and trial-related materials.
- Perform site management activities and provide ongoing updates of site status to Clinical Project Managers.
- Conduct remote monitoring and complete related activities in accordance with study-specific Monitoring Plans.
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP.
- Assist with project-specific activities as a member of the Project Team.
- Participate in the development of CRFs and other study-related documents, including subject worksheets, Monitoring Plans, and Patient Information sheets.
- Perform translation, customization, and review of Patient Information sheets and Informed Consent, protocol synopsis, and other study-applicable documents as per required procedures.
- Provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committees, Institutions Ethics Committees, Regulatory Authorities, Competent Authorities, or Institutions Administration Boards, and follow-up on the evaluation process until approval is available.
- Provide regular updates to Sponsor/Client.
- Support or oversee contract negotiation with study sites, Investigator payments, and tracking of site payments.
- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.
- Identify and anticipate site issues and implement corrective and preventive actions or escalate as appropriate.
- Liaise with Clinical Data Management for data cleaning activities.
- Serve as a mentor/trainer for CRAs, including conducting training/assessment visits.
- Function in the role of Lead CRA for assigned projects.
- 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources.
- Bachelor's Degree or higher in an allied health field, such as nursing, pharmacy, or health/natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years of clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources.
- Previous experience in conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO.
At CTI Clinical Trial Services, Inc., we recognize that our people are what make our company successful. Our work moves medicine forward. We treat our team members with the respect they deserve, and our numbers show it:
- We support career progression – We believe in promoting from within and have a structured mentoring program and program for recent graduates to provide the support employees need to move forward.
- We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department.
- We value our people – We have never had a layoff in our three-decade history and guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work-from-home schedule, and paid parental leave.
- Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry.
- We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
- We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs.
- Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market.
