Senior Clinical Research Associate

Senior Clinical Research Associate

02 Nov 2022
Massachusetts, Cambridge, 02138 Cambridge USA

Senior Clinical Research Associate



Senior Clinical Research Associate - Ophthalmology

Overview:

The Clinical Research Associate will work independently to implement and monitor clinical trials at participating research sites. This position will ensure that all site visits, monitoring, data collection, reports, and requirements are carried out in accordance with company deadlines, quality expectations, and priorities, as well as collaborate with the company and Vendors to compile study results, reports, and/or track various study documentation.

Location:

50-75% travel, sites primarily along East Coast with some in Midwest and West Coast

Responsibilities:


  • Manage clinical trial sites efficiently.

  • Site qualifying visits, site commencement visits, interim monitoring visits, remote visits, and close-out visits should all be documented.

  • Performs data evaluation, query generation, and resolution independently.

  • Performs research site training.

  • Across departments, effectively collaborates with peers and leadership. Can communicate and create relationships with sites and vendors in a professional manner.

  • Ensure that the Monitoring Plan is followed.

  • Assist sites with audit planning and resolution.

  • Provide regular site status updates to team members and study management, as well as the possibility of updating study management tools.


Qualifications:


  • A bachelor's degree in health or life sciences, or an equivalent amount of years in the sector, is necessary.

  • Minimum of 3-4 years of field monitoring experience

  • Years of clinical operations experience in an FDA-regulated sector, as indicated below; prior sponsor clinical operations experience is preferable; ophthalmology field expertise is necessary.

  • Strong understanding of FDA and ICH/Google Cloud Platform laws and guidelines, as well as clinical monitoring protocols.

  • Experience managing global trials and CROs is a plus.

  • Strong interpersonal skills, attention to detail, and the ability to work well in a team are all desirable qualities.

  • Excellent analytical and assessment skills, as well as judgment and problem-solving abilities.

  • Ability to travel as needed for site monitoring and/or co-monitoring activities, investigator meetings, and vendor visits/audits.

  • Proven ability to use word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) as well as clinical trial master filing systems.

  • 50-75% travel may be required






EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.



To find out more about Real please visit www.realstaffing.com

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