A leading company in the healthcare/medical device industry is currently seeking a CRA to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details:
1) Co-ordinate and monitor domestic and international studies undertaken by the company in support of research, marketing / sales and regulatory objectives with limited oversight / supervision
2) Co-ordinate for all product registration, regulatory submissions and related activities for domestic and international markets
3) Participate in the independent evaluation of study proposals for consistency with company objectives, regulatory compliance requirements, and adequacy of study design
4) Develop and write protocols for company supported studies with input from technical, quality assurance, marketing personnel and appropriate regulatory agencies
5) Initiate and monitor assigned clinical / research studies in compliance with all applicable regulations and company procedures
6) Critically analyze and evaluate clinical data presented in literature or generate as part of company sponsored studies
7) Establish and maintain professional relationships (in person, by phone and email) with clinical investigators and regulatory contacts (agency and distributor) as necessary to support clinical studies and regulatory submissions
8) Compose documents for regulatory communications, including submissions (pre-IDE, 510(k), PMA, CLIA waiver and registration dossiers)
9) Actively monitor status of communications with regulatory agencies and clinical study sites
10) Maintain and manage clinical study and product registration activities in database systems, consistent with company timelines and objectives
11) Construct in-house regulatory files
12) Continue to develop regulatory knowledge of worldwide IVD requirements and co-ordinate assigned product registration activities
13) Support all clinical affairs activities as needed
More questions? Want to know the Salary range? Keep reading.
The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the healthcare/medical device industry is strongly preferred
4) Preference will be given to people have recent experience in clinical research
If you find yourself to be a perfect match for this role, you could be just the person to fill the position. Please apply ASAP.
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.