The Clinical Trial Assistant will interact with sponsors, sites, and vendors to ensure timely and high-quality operationalization of clinical trials while compiling and reviewing documentation for site qualification and regulatory submissions. Responsibilities also include setting up, maintaining, and archiving essential documents in the Trial Master File (TMF) and Clinical Trial Management System (CTMS).
Requirements summary
Candidates must possess a Bachelor's degree in Life Sciences or a related field, along with excellent verbal and written communication and computer skills, including expert use of Microsoft Office. A minimum of 1 year of administrative support experience, experience managing electronic TMFs, and thorough knowledge of ICH-GCP guidelines are preferred or required.
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 Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
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 committed, skilled, and customer-focused individuals to join our winning team as a Clinical Trial Assistant for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.
Job Accountabilities
1.
Interact with study Sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high-quality operationalization of clinical trials in compliance with ICH-GCP and relevant local regulations.
2.
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.
3.
Assist with preparation and submission of regulatory documents to responsible authorities and Institutional Review Boards/Ethics Committees.
4.
Responsible for set-up, maintenance, and archival of studies in the Trial Master File (TMF) and Clinical Trial Management System (CTMS).
5.
Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in TMF.
These files must be maintained in a fashion so that they are continuously available for inspection and completion for archive.
6.
Assist with site identification, feasibility questionnaire development and distribution, and site selection.
7.
Contribute to the development of Clinical Operations documents (i.e., Investigator Site File logs, newsletters, etc.) to facilitate the implementation and management of the clinical trial.
8.
Collaborate with meeting planners and vendors to arrange for Investigator meetings, off-site client meetings (i.e., kick-off meetings), or internal departmental meetings.
9.
Responsible for the shipment and tracking of trial documents (site binders, manuals, guides, etc.) and supplies, as needed.
10.
Track monitoring plan compliance metrics (i.e., monitoring frequency and monitoring visit report submission/finalization).
Issue reminders to monitoring team.
11.
Distribute Suspected Unexpected Serious Adverse Reactions (SUSARs) to investigational sites and complete necessary tracking (acknowledgement of receipts, etc.).
12.
Assist with the download of reports from Electronic Data Capture (EDC) systems and Interactive Web Response Systems (IWRS) to prepare summary of data for Project Managers/Clinical Trial Managers.
13.
Maintain study portals, web sites, or newsletters.
14.
Compile reports progress/status of investigational sites.
15.
Assist with processing of vendor/site invoices and Investigator site payments.
16.
Participate in the development and maintenance of and adhere to departmental Standard Operations Procedures (SOPs) and guidelines.
17.
Collaborate with other team members to prepare, maintain, and complete training on study-specific and/or applicable Sponsor SOPs.
18.
Support sites and internal Clinical Operations efforts to prepare for inspections and/or audits conducted either by Everest, Sponsors, or regulatory authorities.
19.
Assist Clinical Operations team members with Requests for Proposals and other Clinical Operations tasks as needed.
20.
Provide support for Clinical Operations and other functional areas as needed.
Qualifications
1.
Bachelor’s degree in Life Sciences or related field of study.
2.
Excellent communication (both verbal and written) and computer skills.
3.
Expert use of the Microsoft Office suite is essential.
4.
Minimum of 1 year of experience in administrative support preferred.
5.
Experience in managing and maintaining electronic TMFs.
6.
Thorough knowledge of ICH-GCP guidelines and applicable regulations.
7.
Ability to travel a maximum of 5% of working hours is required.
Benefits: & Compensation:
We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com [http://www.everestclinical.com]
Estimated
Salary Range
$45,000 - 65,000.
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
