Sr. Clinical Research Associate Transcend Medical

Job Summary:

Responsible for management and monitoring of clinical trial sites participating in pivotal ophthalmic device studies, assists with project management and providing leadership to less experienced staff and/or contractors.

Receives Direction From: Director, Clinical Affairs

Provides Direction To:

N/A

Primary Functions
To include, but are not limited to the following:
Develops and creates study-specific support documents and tools, such as monitoring plans and guidelines, study guidelines, study trackers, site/CRA training materials, etc.
Interfaces with study vendors (reading centers, equipment suppliers, CRO, contract monitors, etc.) to negotiate/implement work agreements and coordinate delivery of requested services.
Negotiates/implements clinical trial and financial agreements with study sites.
Participates in development and implementation of study patient recruitment strategies and tactics.
Develops and presents Study Coordinator and Investigator Meeting materials.
Plans and implements site start-up activities to optimize performance in accordance with corporate goals. Provides ongoing tracking to assess performance vs. plan.
Oversees set-up and maintenance of study regulatory files.
Provides ongoing tracking and reporting of important study metrics (e.g., subject screening/enrollment/treatments, follow-up visit compliance, queries/subject/CRA, etc.)
Coordinates necessary site visit activities with regional CRAs, reviews site monitoring visit reports and follows up as necessary with study team and/or site regarding outstanding issues.
Coordinates site study supply inventory, including investigational device requests and product accountability.
Performs in-house clinical data review and query generation/resolution activities.
May perform site qualification, study initiation and study close-out visits and prepare monitoring visit reports and other related documents in association with visits.
May perform routine monitoring visits to assigned study sites to confirm compliance with study protocol, IRB and regulatory requirements. Prepares monitoring visit reports and other related documentation in association with visits
Estimated travel within the US required 25 - 33 of the time.
Position Description: Sr. Clinical Research Associate Issue Date: 8-23-2011 Page 2 of 2



Secondary Functions:
To include, but are not limited to the following:
Prepares study protocols, patient consent documentation and clinical study reports.
Participates in data collection form design activities.
Oversees clinical publications library.
Supports OUS in-house study activities as requested.

QUALIFICATIONS
Reasonable employment candidates must have a substantial combination of the following: Education/Training/Experience
BS/BA in biological or health sciences, with nursing/med-tech/medical education experience preferred
5+ years' experience in medical device industry clinical affairs, preferably in the field of ophthalmology.

Knowledge/Skills/Abilities
Excellent knowledge of GCP guidelines, FDA IDE and other regulations applicable to the conduct of investigational devices studies in support of US marketing activities
Good written and verbal communication skills
High attention to detail and excellent organization skills
Ability to positively motivate others to achieve desired results
Self-starting and self-monitoring
Good understanding of ophthalmic terminology and disease states
Good working knowledge of MS Word, MS PowerPoint, MS Excel

Physical Requirements
Able to stand, walk and sit for extended periods of time
Able to travel by air, rail, car
Able to operate personal computer
Able to perform light lifting

Training Requirements
Training in relation to company systems and procedures, as well as individual job duties will be provided by Transcend Medical. The need for additional external training with respect to regulations, industry standards, etc. will be determined by employee's supervisor, and provided as appropriate.

A file documenting employee training is maintained for each Transcend Medical employee.
Job descriptions change from time to time. The company retains the right, at its sole discretion, to modify information contained in this job description. Changes in job description will be discussed with the employee at or before implementation.

Location:	Irvine, CA United States