Job Description

Job Title:         Clinical Research Specialist

Department:     Clinical Affairs

Reports To:      Director of Clinical Operations

Job Type:         Exempt/Full Time

Date:                April 3, 2008

Summary:

The Clinical Research Specialist (CRS) position provides a variety of clinical and regulatory support to the clinical team, with specific responsibilities for ensuring that all communication, documents, contracts, product and training between CoAxia, CoAxia clinical sites and CoAxia Clinical Site Managers (CSMs) are well coordinated to meet the needs of CoAxia and its clinical strategy.

The CRS supports the daily in-house management of clinical studies, in concert with the department Directors and Clinical Data Manager, and organizes and tracks communications and documentation consistent with regulations and internal standard operating procedures. The CRS may also support the data management functions with first or second pass data entry, generation of DCFs and corrections to the database upon receipt of query responses.

Travel to study sites to monitor progress of study and compliance with the protocol and regulations may be needed on a limited basis.

Essential Duties and Responsibilities (but not limited to):

• Provide assistance to regional Clinical Site Managers as requested to facilitate site screening, qualification, training, and procurement of all documentation from sites required for study start and device shipment.
• Set up and maintain filing system for assigned study sites (correspondence, payment, device tracking, IRB approvals, SOPs, audits, monitoring reports, data collection, etc.). Perform periodic audits of files for completeness.
• Help prepare and distribute IRB and study support materials.
• Coordinate with and support field-based Clinical Site Managers, CoAxia's data management, and Core Lab with regard to all elements of CoAxia's clinical trials to ensure clinical site recruitment, patient enrollment, protocol and data collection objectives are met.
• Assist in the development of protocols, case report forms, informed consent documents, final reports, and other clinical documents.
• Assist internal and/or contract monitors in the development of monitoring plans for investigations.
• Keep sites supplied with all required/necessary materials needed throughout trial.
• Assist in facilitating the shipment and/or return of devices to and from the clinical sites.
• Work with accounting as requested to assist with coordination of study-related grant payments and other investigator grants/gifts.
• Communicate with sites before, during, and after the study, as directed by Clinical Site Managers and internal Clinical Affairs needs.
• Assist in the preparation and distribution of departmental SOPs, memos, meeting minutes, presentations, training manuals, newsletters, clinical reports and Investigational Plans.
• Perform other duties as requested.

Qualification Requirements:

   Technical Skills:

• Working knowledge of the FDA IDE/PMA regulations and GCP regulations for medical devices.
• Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail systems. Solid understanding of software capabilities and business applications.
• Comprehensive understanding of medical terminology and familiarity with patient records and documentation.
• Experience providing clinical research support.

   Conceptual Skills:

• Creative problem solver coupled with good judgment.
• High attention to detail and accuracy.
• Ability to manage and prioritize multiple tasks and remain focused on personal objectives with minimal direction.
• Positive, flexible outlook.
• Dependable.
• Strong interpersonal communication skills with the ability to effectively communicate across all levels.
• Proven ability to work effectively alone and in a multi-disciplinary team.
• Presents professional manner and appearance.

Physical Requirements:

CRS position requires up to 10% travel.

Education/Experience:

• Bachelors of Science Degree (technical), RN, or equivalent educational background. Technical degree defined as engineering, life sciences or related medical/scientific field.
• Minimum of two years experience in a clinical research environment, preferably in the medical devices/pharmaceutical industry or relevant experience in a medical/scientific area in a research institution.

This job description is intended to describe the general nature and level of work being performed by employees assigned to this position.  It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.