Site Management Specialist I Outcome Software, Inc.
THIS JOB HAS EXPIRED Description
Engage in company training program to gain knowledge and skills required to independently contact investigative sites and participate in clinical research. Collect, compile, document and support clinical research data via remote site monitoring. May be responsible for the remote monitoring of multiple projects.
Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Under close supervision, collect, track and review study site critical documents used to monitor interest for enrollment of investigative sites.
Document and track all communication (email, voice, fax, call reports) with study site personnel and client interactions, in accordance with study plans.
Under close supervision, coordinate site recruitment and enrollment efforts. Ensure the site is recording data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources in accordance with study plans.
Follow established guidelines in the collection and tracking of clinical data and resolution of data queries in accordance with study plans and client preferences. Under close supervision, evaluate and assure quality of data collected; ensure that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protection.
Assist the clinical team in the filing and archiving of clinical documentation according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.
Under close supervision, monitor site and subject progress, including documentation and reporting of adverse events; identify and escalate need for corrective actions to line manager as appropriate.
Under close supervision, may respond to questions on study procedures/protocol via the study hotline.
Perform on-site co-monitoring and remote monitoring activities as needed or other duties, as assigned.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
Strong interpersonal and organizational skills
Strong written and verbal communication skills including good command of English language
Strong attention to detail
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree or currently enrolled in bachelor?s degree program in health care or other related discipline; or equivalent combination of education, training and experience.
Primary Location: USA-Massachusetts-Cambridge
Organization: USA02 - US Clinical Development Svcs
||Cambridge, MA |
THIS JOB HAS EXPIRED