Senior Clinical Research Monitor
Location: Rockland Massachusetts
Description: Merit Medical Systems Inc. is currently seeking to employ Senior Clinical Research Monitor right now, this vacancy will be placed in Massachusetts. Further informations about this vacancy opportunity please give attention to these descriptions. Rockland, MA
SUMMARY OF DUTIES
Ensure the quality and accuracy of clinical trial collection and consistency of monitorin! g through on-site audit of study documents, including case report forms and source and regulatory documents across multiple sites and studies.
ESSENTIAL FUNCTIONS PERFORMED
1. Audit monitoring of study data and activities to ensure consistent compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies across multiple clinical trial sites and studies.
2. Ensure equivalent monitoring methods and quality between US and international clinical trial sites.
3. Participate in the development and implementation of study protocols and guidelines of data collection procedures.
4. Assist in preparation of study-related documentation such as case report forms, instructional manuals, draft informed consents and progress reports.
5. Participate in qualification of research study sites, including evaluating staff and facility suitability for conduct of a clinical trial protocol.
6. Participate in inv! estigator meetings, initiation of study sites, instruction of ! research staff in scientific and procedural aspects of studies, including protocol-required procedures, adverse event reporting, study data collection and documentation procedures.
7. Review selected records of study activity including case report forms, device/drug dispensation records and other study documentation to ensure consistent monitoring practice and quality among trial sites.
8. Ensure that informed consent is properly obtained and documented in the study files of each patient audited.
9. Determine and resolve barriers to enrollment or accuracy of data collection.
10. Review adverse event data and ensure its completeness and accuracy confirming that SAE information was communicated to sponsor within required timelines.
11. Review quantities of devices and supplies at site to ensure accuracy of recording and traceability.
12. Identify protocol adherence issues and assist in problem resolution efforts.
13. Prepare for or participate in q! uality assurance audits conducted by federal agencies or other regulatory bodies.
14. Assist in closing study sites at the end of the clinical trial.
15. Performs other related duties and tasks, as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
- Lifting -- Not to exceed 50 lbs. â€" local practice may apply.
- Writing
- Sitting
- Standing
- Bending
- Vision
- Color perception
- Depth perception
- Reading
- Field of vision/peripheral
- Fine motor skills
- Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline and six years of related experience.
- Education and clinical experience equivalent to a Registered Nurse is preferred.
- Knowledge of cGCPS, ISO 14155, and MDD requirements.
- Demonstrated knowledge of regulatory affairs.
- Demonstrated site m! anagement and effective communication skills â€" verbal and written.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
- Strong organizational skills and the ability to be self-motivated and be detailed oriented.
- 90% domestic and international travel required.
- Study compliance/protocol monitoring
- Local/state/federal regulatory and institutional policies
- Study documentation preparation/review/evaluation
- Research site qualification
- Computer skills
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
TO APPLY
Please submit an application along with your resume on our website under the “Careers†tab in order to be c! onsidered.
Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice. Excellent compensation and benefits packages will be offered to the right candidate.
COMPANY HISTORY
Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos and Kent W. Stanger, Chief Financial Officer. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and cath! eter technologies. The Company is utilizing its competitive advantages ! and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Merit Medical Systems Inc..
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This vacancy starts available on: Sun, 03 Nov 2013 10:49:09 GMT