The Clinical Trial Specialist (CTS) will support the Clinical Trial Managers to ensure the success of current and future clinical trials at AMT. The CTS will work with the CTM to assist with the planning and implementation of multiple studies within a clinical development program. The position will also work closely with other cross-functional representatives including Regulatory, Clinical Development, Project Management, and QA to ensure successful completion of all clinical activities/project deliverables within the required time frame. The position will also support oversight of the CRO and other third-party vendors on the assigned study. This individual will report to a Clinical Trial Manager.
- Assist CTMs with activities related to study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment.
- Assist with tracking, reviewing, distribution, and storage of key internal and external documents such as investigator brochures, protocols, interim safety reports, and site/subject material, through the course of the study.
- Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor metrics, and Enrollment metrics.
- Assists CTMs with the oversight of CRO(s) and other study-related, third-party vendors to ensure study requirements are met and study documents are delivered to the Sponsor in a timely manner.
- Track study wide clinical supply inventory, vendor supplies at sites and management of study samples.
- Ensures electronic trial master files (eTMF) are compliant with relevant regulatory requirements by performing periodic and ad hoc reviews/audits of TMF. This includes the reconciliation of the TMF at study close-out and responding to TMF related inquiries.
- Maintains and ensures all documentation is in a state of audit-readiness.
- Utilize project management tools (e.g. Outlook, Word, PowerPoint, Timelines, Excel) in order to plan and execute effective meetings with appropriate materials and balance scope and schedule for each trial.
- Creates meeting agenda/minute templates and provides drafts of meeting minutes.
- Support clinical team efforts to track and contribute to regulatory submissions in the US and globally by coordinating and tracking approvals of clinical documents.
- Ensures Good Clinical Practices are followed, ensures protocol deviations are properly recorded, SOPs are maintained and routinely updated, and CRO/site audits are tracked.
- Coordinate collection, tracking, and maintenance of updated site regulatory documentation (i.e. FDFs, 1572s, CVs, IRB approvals, etc.).
- Develop working knowledge of company standard operating procedures (SOPs) and familiarity with FDA and global regulations related to clinical studies.
- Participates in organizing investigator meetings including venue selection, invitations, agenda, and materials distribution.
- Communicates effectively with members of the AMT and vendor project teams.
- Other tasks or responsibilities as assigned.
- A Bachelor’s or Associate’s degree is required. A BA or BS in biological sciences, nursing, or related field is preferred. Prior CTA experience and exposure to clinical trial operations is preferred.
Knowledge, Skills and Abilities:
- Knowledge and/or experience of operational aspects of all stages of clinical studies, knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Familiar with using eTMF, EDC, IRT, CTMS, SharePoint and other vendors systems/portals.
- Thrives in a dynamic start‐up environment with busy, high performing colleagues; flexibility to wear multiple hats as needed.
- Ability to learn quickly and effectively using newly acquired skills, ability to use time efficiently, multi-task, prioritize, track projects, and follow-through on-time with assigned tasks with exceptional attention to detail.
- Excellent organizational and communication skills: Is able to listen and follow instructions; asks questions or clarifications as needed; is transparent and able to communicate clearly and effectively.
- Demonstrates accuracy, thoroughness, and thoughtfulness; is able to assess strengths and development areas; Provides quality deliverables and strives to continuously build knowledge and skills.
- Strong work ethic; A motivated, positive minded individual who is proactive, flexible and solution oriented to address changing program needs in real time.
- Team player who is collaborative, accountable, self-aware; works well in a team environment but can also work independently without significant oversight.
- Contributes to building a positive team spirit and company culture; Supports everyone’s efforts to succeed; Shares expertise with others.
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
We invite qualified candidates to submit their CV to: email@example.com (note: ‘Please put job title in subject heading)
AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets