Full-Time Clinical Trial Associate II
The Clinical Trials Associate II reports to the Director, Clinical Operations and is responsible for processes involved in the planning, initiation, conduct, tracking, and completion of clinical trials in accordance with regulations and SOPs. The CTA II uses solid judgment and independent decision-making to assess and manage technical study documents and key clinical monitoring activities, and is a resource for CTA Is. The CTA II manages the Trial Master File (TMF) for assigned studies and establishes and maintains the electronic clinical trial management system (CTMS) for assigned studies. The CTA II liaises with and provides direct oversight of clinical vendors in the event these functions are outsourced.
Develops/revises tools and instructional materials in support of clinical trial monitoring, including project, communication, monitoring, recruitment, and contingency plans.
• Provides published versions of the protocol and amended protocols to key stakeholders, such as Drug Safety.
• Collaborates with CTMs to manage the clinical areas of project-specific SharePoint sites.
• Leads cross-project teams in assessing contract Clinical Research Associate (CRA) needs and schedules.
• May lead study event planning, such as Investigator Meetings, by compiling materials and meeting presentations and scheduling activities. Supports the CTM, and may have responsibility for, activities related to designated clinical meetings, communications, correspondence and associated documentation.
• Maintains up-to-date electronic(if applicable) and paper-based TMFs, and uses judgment to determine TMF status and compliance with guidelines, regulations and SOPs:
· Setting-up, managing and maintaining necessary and appropriate clinical trial master files (TMF) in accordance with SOPs , guidelines, and regulations
· Performing project quality assurance activities consistently, to include reviewing all contract CRA TMF submissions and CTMS entries, providing follow-up to CRAs and refresher training to ensure adherence to directions and SOPs, accurately tracking sources of all TMF submissions, independently auditing internal TMFs, providing CTM with TMF access.
· Performing project quality-assurance activities as required, which may include clinical site audits of regulatory files and CRO audits of outsourced TMF activity.
· Archiving all documents for completed clinical trials
· Entering data into CTMS, including site contact information, approval dates, expiration dates, license information, etc., and providing information as needed.
· Collaborating with colleagues in Clinical Operations and colleagues in cross-functional department such as Quality Assurance, Drug Safety, and Medical Sciences, to ensure, with minimal direction, that training for CRAs is completed and appropriately documented
· Checking and tracking all debarment certifications at study start-up; checking and tracking all financial disclosures at study start-up and one year post clinical trial.
• Participates in the tracking and reporting of clinical trial metrics and progress of clinical trials.
• Analyzes work processes for efficiency, suggests and makes improvements for project work processes. Ensures workflow continuity, informs team members when concerns arise and determines appropriate escalation to next level of management; communicates and follows-up on required issues and action items in a timely manner.
• Ensures consistency, quality, and uniformity in processes by partnering with colleagues and peers to ensure best practices.
· Independently assesses clinical trial-related regulatory documents for quality and accuracy, uses judgment to determine corrective actions, and collaborates with clinical sites in resolving questions and obtaining corrected documents.
Maintains timely understanding of up to date federal regulations and guidance as well as internal SOPs.
Develops, forecasts, and coordinates clinical trial monitoring activities at the study and site level for assigned Phase 1 clinical projects. The CTA II participates in internal cross-functional teams and ensures that the contract monitoring resources are scheduled efficiently and trained appropriately.
In collaboration with the CTM, coordinates and independently performs clinical trial start-up activities at the site level, including requesting, reviewing, and verifying regulatory documents required for site initiation. and drug release. Manages study supplies. Generates Investigator Site File and ensures timely delivery to the site, inclusive of Investigator Brochure, protocol, and other clinical-trial specific documentation.
Education: Bachelor’s Degree in Science preferred. Relevant experience may be considered in lieu of a Bachelor’s Degree.
Experience: At least 3 years of experience in a relevant medical/regulatory setting, the pharmaceutical industry, or institutional research
Knowledge of cGCP, ICH and FDA regulatory requirements is required.
Strong organizational skills with attention to detail and effective internal/external customer interface skills.
Previous exposure to CTMS preferred
Able to work to high standards in a matrix environment and interact well with all levels of the company with limited direct supervision.
Mature professional with strong interpersonal, oral and written communication skills and the ability to work effectively in a cross-functional team setting.
Able to handle multiple complex priority tasks while maintaining quality and flexibility to meet deadlines.
Able to focus on, and adjust priorities during peak volume times
Able to solve complex problems with minimal or no direction
Additional Skills/Competencies: Strong computer skills; must be proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint).
Experience with MS Project preferred
Infrequent overnight travel may be required.
How to ApplyIf interested in learning more about the opportunity and applying, please visit the link below: https://mallinckrodt.wd5.myworkdayjobs.com/MallinckrodtCareers/job/US-Specialty-Brand-Headquarters---USA501/Clinical-Trial-Associate-II_JR000010182
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