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Site Management Associate Outcome Software, Inc.
THIS JOB HAS EXPIRED
DescriptionOutcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management.
Purpose:
The Site Management Associate within Late Phase (outcome) remotely supports physicians, nurses, pharmacists, research coordinators and other healthcare workers in use of the company's internet-based tools (EDC) and in all aspects of post-marketing registry management through phone and email support. Provides in-house support to CRA Is, CRA IIs and contract CRAs. Follows established SOPs, GCP (when applicable) and other applicable regulatory requirements in the execution of all activities. Proactively identifies and escalates or resolves operational project issues and participates in process improvement initiatives as required.
Primary Responsibilities:
Serve as primary contact for all site interactions (phone and email support) involving the company's EDC by providing basic administrative support
(password reset, account set-up) and study-related support (query resolution, data entry, EDC system functionality); documents communication with sites in a timely manner; may include up to 80% of time spent providing phone support
Perform comprehensive trainings on the company's EDC for sites (web based
trainings) and internally to the team
Assists and support study start-up activities (i.e., site recruitment, regulatory document collection, IRB submission) including the review of clinical and
project-related documents (i.e. protocol, case report form, Informed Consent, monitoring plan, site recruitment plan, source documents, training manuals,
study binders, patient contact material, etc.)
Conduct patient outreach activities (inbound and outbound calls) in order to complete or facilitate patients' completion of registry questionnaires
Utilize internal databases to track and manage site/client contacts, patient enrollment, and other registry-specific reports, and provide reports to Project
Management/CRAs/client in a timely manner
Investigate, track, prioritize, and resolve site/client user feedback, complaints and issues. Has the ability to recognize and escalate issues where appropriate and choose appropriate method of communication
Provide administrative support by preparing, organizing, managing, and tracking registry supplies such as, but not limited to: patient questionnaire
mailings, patient gift cards, study manuals, collecting, filing and tracking regulatory documents
Prepare and disseminate registry correspondence and assist with the creation of registry-specific manuals, tools and templates
Ability to prepare appropriate, timely and accurate communication to internal and external registry teams, consultants and investigative site personnel.
Act as site liaison to CRAs/Project Managers
May be expected to lead site management activities for a study: oversee, train and coordinate participating sites
May perform other duties as applicable
Qualifications
Requirements:
Bachelor's degree, preferably in a health or life science concentration
6 months - 1 year of clinical research experience, study coordinator, data management preferred, but not required
Must be detail oriented, enthusiastic, self-motivated, eager, and have a strong customer service sensibility
Ability to handle multiple tasks and work on multiple project teams simultaneously
Strong organizational skills and self-motivated with the ability to work independently or as part of a team
Excellent verbal, written communication and interpersonal skills
Must be proficient in Microsoft Office
Must have professional demeanor
Understanding of GCPs and knowledge of regulatory requires, but not required
bilingal is a plus
| Location: | Cambridge, MA United States |
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THIS JOB HAS EXPIRED
Outcome Software, Inc.
All Jobs: at Outcome Software, Inc.| Web Site: | www.outcome.com |
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| Headquarters: | 00000 United States |
| Industry: | Healthcare Services |
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