- Prepares, processes, distributes, updates and maintains (filing and archiving) clinical study documentation in an electronic format. Ensures study compliance with SOPs and regulatory guidelines. Ensures TMF/eTMF is FDA-inspection ready at all times while the clinical trial is being conducted. Provides access to the systems when applicable.
- Creates a documentation system chronicling all incoming/outgoing clinical documentation, maintains study supply documentation, reviews Study Folder regularly to ensure file accuracy and completeness, maintains study specific metric tracking and reviews Clinical Research Associate (CRA) field monitor reports and any necessary follow-up letters in relation to specific Study Monitoring Plan, contacting CROs and CRAs, as required. Provides oversight of Regulatory documents for site activation.
- Tracks study progress including site contracts, patient enrolment and patient status, and provides QC oversight of the CRO, TMF, QV Reports, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
- Contributes to the development and updating of Clinical Operations SOPs and ensuring contribution to Clinical Operations process improvement within the clinical operations team and company in general.
- Schedules Clinical Operations, study team, investigator and partner meeting, preparing/distributing required materials, and taking and distributing minutes, as required.
- Contributes to the 3rd party vendor qualification process (e.g. getting their financial condition utilizing a specific vendor, checking if there is an unacceptable risk of bribery or corruption using a specific checklist).
- Creates and/or reviews the study plans, specification documents, materials, and tools.
- Creates and maintains project databases (e.g., contact list, competitive study list), facilitates and tracks study payments following the internal approval process.
- Processes and tracks payments to vendors and study sites as appropriate. May be required to perform other duties, as assigned.
- Keeps abreast of the broad context of the industry related to commercial operations, regulations, best practices, relevant technologies and innovations. Understands the implications for the assigned area and implements innovative operations approaches to help ensure efficient operations and achieve mandate.
- Tracks and ensures training of the study team.
- Perform administrative tasks associated with the CTA role and responsibilities, as well as supporting other clinical operations team members.
- Associate's Degree, or the equivalent in work experience, preferably in the life sciences.
- 3+ years of clinical trial management experience in the pharmaceutical/biotechnology industries, or with a Clinical Research Organizations (CROs) or a clinical research site
- 1+ years of Clinical Operations work experience.
- Knowledge and experience creating, organizing and maintaining eTMFs.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.
- Knowledge of the Pharmaceutical Industry Clinical trial process (clinical trial conduct, documentation and reporting) in accordance with ICH/GCP and other regulatory compliance guidelines.
- Problem solving capabilities to align with independent assignments requiring limited supervision.
- Demonstrated ability to effectively manage and problem-solve several complex studies with rigorous timelines; provides high-quality work resulting from attention to detail and accuracy; successfully interacts and communicates with multiple internal and external process owners.
- Strong verbal and written communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams so as to build commitment.
- This role may require the incumbent to occasionally travel (domestic) to attend meetings. Travel will be scheduled based upon the needs of the business.
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Sr. Clinical Trial Associate, Clinical Operations - Cambridge, United States - The Steely Group
Description
Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation, in accordance with study timelines from study initiation through to study closeout.Responsibilities:
Requirements / Qualifications:
