Clinical Research Monitor

Ophthalmic Research Associates (ORA), established in 1976, is based in North Andover, MA. ORA specializes in the research and development of drugs and medical devices for the ophthalmic pharmaceutical industry. ORA provides a stimulating work environment and tremendous growth opportunities as well as a unique compensation and benefits package.

We are seeking Clinical Research Trial Monitors for Full-Time positions. Individuals must be organized, detail-oriented and have excellent communication skills. Both regional and local travel may be required.
REQUIREMENTS
Qualifications include:

- 2+ Years Experience Monitoring Clinical Trials.
- Registered Nurse with recent extensive clinical background, Ophthalmology a plus.
- Ability to correlate medications with appropriate disease indications.
- Experience with initiation, close-out, and interim monitoring visits at assigned investigator sites.
- Maintain a Study Binder at each investigator site that contains all required regulatory documents and
ensure that all documents are accurate and up to date.
- Monitor patient consents to ensure FDA compliance.
- Conduct drug accountability reviews at investigator sites.
- Familiarity with GCP Guidelines
- Review study site data to ensure compliance with study protocol.
- Attention to detail.
- Experience with review of and extraction of pertinent medical history in an expeditious manner.
- Medical chart review to determine accuracy and identify supportive documentation to meet protocol
guidelines and or governmental regulatory compliance

- Ability to work independently and with a variety of professional and para-professional staff.
- Fluency in medical terminology, disease diagnosis and pharmaceutical therapy.
- Verify CRFs with source documents.
- Track serious adverse events (SAEs) and reporting at investigator sites.
- Work with sites to resolve data queries in a timely manner.
- Assist the development of protocols, consent forms, and CRF’s.


Please send resume to:
William Nabozny
Ophthalmic Research Associates, Inc.
138 Haverhill Street, Suite 104
Andover, MA 01810
Email: [Click here for email]