Clinical Research Administrator

Helping Hearts Heal Themselves

AGA Medical Corporation specializes in the development and manufacturing of innovative medical devices for use in cardiovascular applications. AGA's patented AMPLATZER family of occlusion devices offers new and enhanced solutions for transcatheter treatment of complex congenital heart defects. We are a fast-growing, innovative company, looking for creative professionals to join our team.

We are currently seeking a Clinical Research Administrator (Monitor) to design, implement, monitor and close out clinical investigations. Duties and Responsibilities include:

Follows department Standard Operating Procedures.
Monitors clinical investigations to assure protocol compliance per applicable regulations, assure subject rights, safety and welfare are protected; and assure data integrity through completeness, accuracy, legibility and logicalness.
Assists Clinical Research Associate in setting up sites (Clinical Research Agreements, IRB Approvals, etc.).
Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations.
Assists in organizing Investigator and Data Safety Monitoring Board meetings.
Data entry verification.
Conducts field audits to assure protocol compliance and data integrity.
Generates presentations when requested by investigators or AGA personnel.
Generates follow-up reminder reports and sends to investigators on a regular basis.
Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries.
Acquires professional, product and market expertise via independent reading, networking and training.
Travels approximately 40%.
Participates in professional activities outside of normal business hours. REQUIREMENTS
BA/BS in business, medical science or nursing (or equivalent experience).
1-3 years experience in clinical research, preferably in a medical device company.
Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization.
Excellent written and verbal communication skills.
Ability to work independently and take direction from others.

For a more detailed job description, please visit our website at www.amplatzer.com.

We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.

An Equal Opportunity / Affirmative Action Employer

Please, No Agencies