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| Job #02298 |
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| About our client |
| Our client is a privately held medical technology
company founded in 1999. It develops, manufactures and markets innovative
technologies for the treatment of gastrointestinal disease. |
| Position |
Location |
| Senior Clinical Research Associate |
Massachusetts |
| Salary |
Reports to |
| Highly competitive package, commensurate with experience |
Management |
| Responsibilities |
1) Develop clinical protocols, case report forms,
informed consent forms and monitor guidelines for clinical evaluations
2) Participate in the ID, qualification and selection of clinical sites
3) Provide training and orientation of clinical study sites relative to clinical
protocols as well as applicable external regulations (e.g. GCP)
4) Ensure all necessary study documents and materials are available to clinical
sites in order to ensure proper execution of clinical studies
5) Manage and oversee clinical study device accountability
6) Provide in-depth clinical site management and ensure adherence to clinical
protocols and QSR, GCP, ISO, EN and MDD regulations
7) Ensure that collected clinical study data is complete, accurate, processed
properly and maintained properly
8) Collaborate with data management CRO to resolve all data anomalies
9) Ensure timely access to clinical databases for reports and manuscripts
10) Demonstrate, assess, interpret and accurately summarize clinical data
11) Prepare clinical reports for use by regulatory, physicians, investors and
marketing
12) Participate in and contribute to the preparation of regulatory filings, such
as IDEs and 510(k)s
13) Provide job specific training and mentoring to junior clinical staff
14) Demonstrate working knowledge of appropriate application of clinical
research conduct, laws, regulations and standards, etc.
15) Review related publications, articles and abstracts to stay abreast of
relevant developments
16) Develop and manage project milestones and timelines
17) Provide input into the overall clinical budget and manage clinical studies
within approved budgets and timelines
18) Develop site budgets, manage budget negotiations and clinical study
agreement process
19) Support R&D on new product development concepts and clinical needs
20) Ensure that clinical studies are ‘audit ready’ at all times
21) Manage one or more clinical trials at the same time |
| Requirements |
1) Bachelor’s of Science Degree in Nursing, Life
Sciences, or a related medical/scientific field
2) An advanced degree and/or experience in case proctoring or clinical safety
surveillance management preferred
3) 4 years of experience in monitoring or management of clinical trials
4) In-depth knowledge of FDA and ISO regulations relating to clinical trials
5) Ability to stick to timelines and/or corporate goals
6) Demonstrated success in managing multiple complex projects
7) Ability to motivate
8) Ability to perform each essential duty and responsibility successfully
9) Willingness to travel – up to 50% of working time (domestically and
internationally) |
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