Clinical Trials Administrator I

**Clinical Trial Administrator - FSP**

**Hybrid Office/Home-Based - Montreal, Quebec**

**Must be bilingual (English/French)**

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

**Did you know?**

**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. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

**Essential Job Duties**:

- Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies
- Maintain the Project Directory
- Provide support to project team (study related mailing, bill processing, printing, translations, etc.)
- Collect and distribute documents from / to sites during study life cycle
- Coordinate study related materials (i.e. protocol, Informed Consent Form(ICF), patient material) for translation
- Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding
- 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
- Coordinate and plan study supply shipments with vendors
- Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery
- Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO
- Generate reports as needed, for example CTMS site contact information list
- Work with other 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.

**Education / Qualifications**:

- Degree within Life Sciences area, Administrative, Financial or Accounting related field preferred, or minimum 2 years working experience in any of these areas in addition to high school degree or local equivalent

**Experience Required**:

- Minimum one (I) year experience in Clinical Research or related work experience
- Must be bilingual (English/French)
- Good oral and written communication skills
- Good organizational and time management skills
- Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow
- Basic understanding of GCP, ICH Guidelines and local regulations as they apply
- Ability to manage multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals
- Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint)
- Ability to function independently

**Preferred**:

- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent
- Works efficiently and effectively in a matrix environment

**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 discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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