Clinical Trial Assistant

7 months ago

Markham, Canada Everest Clinical Research Full time

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength that’s us that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a **Clinical Trials Assistant **for our Toronto/Markham, Ontario, Canada, on-site location.

The Clinical Trials Assistant provides support to Clinical Operations for departmental and project-related requirements.

**JOB ACCOUNTABILITIES**:

- Interact with personnel from study sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high quality initiations and completions of clinical trials.
- Compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
- Assist with preparation and submission of regulatory documents to responsible authorities and IRB/ECs.
- Responsible for set-up and maintenance of studies in Clinical Trial Management System (CTMS) and Trial Master File (TMF).
- Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in Trial Master Files. These files must be maintained in a fashion so that they are continuously available for audit and completion for archive.
- Contribute to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include, study guides or manuals, and information collection tools.
- Assist in working with meeting planners and vendors to arrange for investigator meetings, off-site client or internal departmental meetings.
- Responsible for the shipment and tracking of trial documents (site binders, manuals, guides, etc.)
- Record and inventory visit reports received from monitoring staff.
- Maintain study portals, web sites, or newsletters.
- Compile reports progress/status of investigational sites.
- Assist with processing vendor invoices, investigator payments, and expense reports.
- Prompt staff to provide timely and accurate reports of travel expenses.
- Participate in the development and maintenance of, and adhere to departmental SOPs and guidelines.
- Prepare, maintain, and complete training on study-specific and (or) applicable sponsor SOPs.
- Support sites in their efforts to prepare for audits conducted either by sponsors or regulatory authorities.
- Plan and carry out professional development.
- Provide support in Clinical Operations or other functional areas as required.

**QUALIFICATIONS**:

- Bachelor’s degree in Life Sciences or health-related field preferred.
- Excellent command of verbal and written English.
- Expert use of the MS Office suite is essential.
- Minimum of one year of experience in administrative support required.
- Knowledge of ICH-GCP.
- Experience in organizing Trial Mater Files desired.
- Ability to travel a maximum of 5% of working hours is required.

We thank all interested applicants, however, only those selected for an interview will be contacted.

LI-Remote
LI-MG1

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