Senior Clinical Trials Assistant

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POST DATE 8/16/2016
END DATE 11/23/2016

Alere San Diego, CA

Company
Alere
Job Classification
Full Time
Company Ref #
08352
AJE Ref #
575891196
Location
San Diego, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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SUMMARY

The Senior Clinical Trial Assistant (CTA) is an integral member of the Clinical Affairs Department in the execution of clinical research investigations. Working under minimum supervision, the Sr. CTA is responsible for providing quality administrative support to our clinical research studies and the overall Clinical Affairs team. The Sr. CTA is also responsible for the overall administrative management of the Clinical Affairs department including the organization and maintenance of study equipment, management of investigational product inventories and the maintenance of clinical systems that track activity, compliance, performance and timelines.

TASKS AND RESPONSIBILITIES:


* Work independently and within a team environment to meet study objectives and timelines,
* Assume responsibility for completing assigned tasks in a timely manner, requiring minimal ongoing direction and supervision
* Assist study teams by coordinating the ordering, tracking, and accountability of clinical supplies, including investigational product materials, equipment, and special-order items as requested
* Provide senior level support in the preparation, handling, distribution, filing and archiving of clinical documentation, and assisting with periodic file audits
* Coordinate with the clinical trial managers (CTM) and all other Clinical team members on the planning of study supplies needs (i.e., lab supplies, barcodes, binders, etc) and placing orders
* Assume responsibility for processing study supply requests from internal and external contacts, and the shipping and tracking of all study supply shipments
* Coordinate and manage the assembly, tracking, maintenance and distribution of lab kits
* Contribute to, and participate in, study dry runs, pre-study planning activities, departmental and project specific meetings, ability to take, finalize and file meeting minutes
* Function as the central Clinical Affairs contact for department wide communications and events
* Maintain a working understanding of current applicable regulations, SOPs, WI and guidance documents, such as FDA Code of Federal Regulations (CFR), ICH Guidelines on Good Clinical Practices (GCP), and Aleres Quality System
* Responsible for remaining current with all applicable departmental and corporate SOPs (standard operating procedures), WI (work instructions) and procedures
* Demonstrate commitment to the implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies
* Exhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the companys policies and practices
* Perform other duties & projects as assigned

PREFERRED EDUCATIONAL BACKGROUND:
BA/BS in science or related field or equivalent with coursework directly applicable to duties or equivalent combination of education and experience.

QUALIFICATIONS:

* A minimum of 3-4 years experience in clinical research or a related field, with particular skills and knowledge of clinical study activities
* Strong written and verbal communication skills
* Demonstrated computer skills including proficiency with Microsoft Office programs: Outlook, Word, Excel and PowerPoint
* Strong attention to detail and the ability to QC own work
* Effective organizational and time management skills
* Ability to apply training and knowledge to every day work load
* Demonstrated ability to foster and maintain effective working relationships with co-workers and project team members and, demonstrated professionalism with all internal and external contacts
* Ability to balance conflicting priorities and manage multiple projects and timelines
* Ability to safely handle and work with human specimens including blood, blood related products and urine