This position participates in clinical research programs by assisting with the development of study protocols, case report forms, clinical reports, performing site monitoring visits, and interfacing with site coordinators, field clinical staff and other company representatives.

Responsibilities and Duties include, but are not limited to:

• Ensure documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
• Assist in designing, planning and implementing clinical research projects
• Assist in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process
• Review study records including case report forms, consent forms, and other materials
• Assist site coordinators, investigators, and field clinical staff, in collecting data in a timely manner that meets the protocol requirements
• Organize data in systematic manner to allow for efficient and accurate clinical reports
• Perform site visits to ensure regulatory and study requirements are being fulfilled
• Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols
• Assist in writing the clinical portion of Regulatory submissions
• Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.

Travel Requirements:

• Some travel is required for site training, monitoring responsibilities and educational seminars (ability to travel 20-50%).

Experience:

• Bachelor's degree in health profession, science and/or engineering field
• Two to three years experience in the medical device or pharmaceutical industry
• Excellent written and oral communication skills
• Computer literacy, proficient in MS Office, Excel, PowerPoint

Responsibilities and Duties include, but are not limited to:

• Filing, copying, faxing and distributing mail
• Manage office supply processes
• Make travel arrangements
• Maintain the common areas of the office, including copy/supply rooms, kitchens and conference rooms
• Assist various departments with special projects as needed

Experience:

• Bachelor's degree in general business administration preferred
• Two years experience in administrative support is desired
• Experience working in a fast-paced environment
• Knowledge of Microsoft Office (Word, Excel, PowerPoint) required
• Experience with FileMaker Pro and Visio software packages helpful
• Experience booking travel arrangements preferred
• Excellent organization and prioritization skills essential

Working Conditions:

• Lift up to 40lbs on occasion

Perform a variety of manufacturing operations in a clean room environment. Operations to include vial and syringe fill and finish operations, buffer preparation and kit packaging of finished goods product.

Experience:

• Two to three years experience in medical device assembly preferred
• Ability to read and understand assembly drawings is required
• Ability to write and communicate in English
• Good manual dexterity and attention to detail is a must
• Ability to work well in a group environment