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Clinical Research Associate (Rockland, MA)

SUMMARY OF DUTIES
Responsible for assisting the study team in conducting clinical trials in various therapeutic areas. Contributes to clinical research study development, implementation, conduct, and management of medical device studies.
ESSENTIAL FUNCTIONS PERFORMED
Contribute to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.
Assist in developing and overseeing study operational plan(s)
Contribute to study team for trial start-up, conduct, and close-out activities according to industry and corporate standards
Participate in study data review and assist with patient outcome narrative writing and other data review activities as assigned
Participate in initiation, training and monitoring activities at clinical trial sites to ensure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols; take ownership for data completion and accuracy
Contribute to the creation of study documentation including clinical protocols, study tools, informed consent, investigator brochures, and clinical study reports
Perform other related duties and tasks, as required.
SUMMARY OF MINIMUM QUALIFICATIONS
BS in Science, Life Science or related field a plus
1-3 years' experience in medical device, pharmaceutical drug development, biotech or CRO industries
Excellent knowledge of ICH/GCP including relevant Guidance documents from (FDA, ICH, and EMEA etc.)
Willing to be held accountable for deliverables
Must be highly organized and detail oriented
Experience interfacing with multiple vendors/contractors
Proven ability to handle multiple projects and changing priorities
Must be results-driven and exhibit a sense of responsibility and outcome ownership
Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information
Strong initiative and positive attitude
Ability to travel to clinical sites, domestic and foreign, up to 25%.
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.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. 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 catheter 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.
MERIT MEDICAL SYSTEMS, INC.
www.merit.com
EQUAL OPPORTUNITY EMPLOYER M/F/D/V
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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