New England Research Institutes
9 Galen Street
Watertown, MA 02472
Senior Research Associate
· Coordinate directly with sites to manage positive relationships; maintain/edit study documents including manual of operations, protocol and consent documents; and distribute appropriate study materials;
· Assist with site staff training and build relationships with site staff to ensure protocol adherence and quality data submission;
· Monitor clinical site Ethics Committee approval status and provide guidance/support as needed;
· Interact direct with study subjects, including obtaining informed consent and data collection;
· Draft clinical site newsletters.
· MPH/MA/MS in a related filed and 2 plus years of research experience or a Bachelor’s degree in a social or biological science disciple and 3 plus years of research related experience;
· Working knowledge of principles of clinical research, including GCP, ICH and FDA. Familiarity with international research regulations/guidelines would be helpful, but not required.
· Excellent oral and written communication skills – including e-mail;
· Ability to manage relationships with clinical sites, both remotely and on-site;
· Ability to provide technical direction and training to sites;
· High level proficiency with Microsoft Office applications, with an emphasis on Excel and Query. Experience with or interest in learning SAS is helpful;
· Ability to manage projects independently while working on a team.
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