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Clinical Trial Associate (Temporary) - United States  

Company managed [?] Still accepting applications

Posted on : 25 April 2017

Project Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Duties

The Clinical Trial Associate  position is a key support role within Clinical Operations, undertaking essential coordination activities for the study team.

Assist with study coordination activities, including:

Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates
File, track and maintain TMF
Maintain internal/external contact list
Conduct electronic documentation and records management
Perform document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation
Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)
Ensure timely study entry and updates to ClinicalTrials.gov
Prepare investigator meeting materials
Design and prepare study related materials for the training of internal and external staff

Assist with study conduct activities, including:

Startup:

Facilitate CDA and contract execution. Assist with regulatory package review

Request and distribute insurance certificates for sites – as delegated by, and under the oversight of, Study CRA or Study Lead

Contact and identification of investigators for participation in clinical studies

Enrollment and Maintenance:

Issues identification, resolution, and escalation

Track site payments and vendor invoices

Closure:

Conduct study closure activities (sites, reconciliation activities, filing & archiving)
Track, collate clinical trial documentation related to CSR appendices

Skills

2-5 years of clinical research experience, preferrably within biotech or pharm industry.

Education

Bachelor’s Degree desired and/or equivalent experience in Life Sciences, Nursing, or related disciplines


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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.