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Clinical Trial Administrator
3 months ago
Clinical Trial Administrator
Montreal, QC
Hybrid 50% client office / 50% home-based
Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.
Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research.
We are seeking a Clinical Trial Administrator (CTA), an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.
The degree of responsibility given to the CTA shall reflect their experience, and the level of contribution which they can make to the project.
The CTA performs study-related tasks as required by the department, including (but not limited to):Responsibilities:
The CTA is an administrative support role for clinical trials.
The role responsibilities include but not limited to the following activities:
- Communicate with project team members regarding study updates
- Maintain documentation as required by protocols SOPs and regulatory standards, to ensure timely production of highquality clinical data, provide systems support, track information related to the status of study activities and assist with general administrative functions as required.
- Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable.
- Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support
- Assist in the preparation of study and sitespecific materials in accordance with relevant SOPs
- Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies
- Maintain the Project Directory
- Provide support to project team (e.g. proofreading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.)
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable
- Audit and CAPA tracking
- Set up and maintain clinical investigator files and documentation
- Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members.
- Coordinate and plan study supply shipments with vendors
- Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery
- Prepare/assemble/ship supplies to sites preSIV: Study File Notebooks, CRFs, other studyspecific ancillary supplies (i.e. diary cards, patient visit reminders).
- Generate reports as needed, for example CTMS site contact information list
- Work with other clinical operations project team members on reconciliation of data with CTMS.
- General communications to sponsors, sites and internal team members via electronic mail or courier or telephone
- Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
Minimum Requirements:
- Able to work independently as well as part of a team.
- Ability to manage multiple priorities and able to accomplish tasks within a timeframe including setting milestones to meet deadlines and to achieve goals.
- Willing and able to support clinical operations team with report running, communications, and information management as needed.
- Basic understanding of ICH GCP Guidelines and local regulations
- Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.
- Proficient English and French skills, conversational and written.
Education:2 year degree required, 4 year undergraduate degree preferred
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Experience:Minimum
1 year experience in clinical research or related work experience
Preferred:
- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems
Great Benefits at Labcorp:
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:
- Medical
- Dental
- Vision
- Life, STD/LTD
- 401(K)
- Employee Stock Purchase Plan (ESPP)
- Paid time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimin
