Principal CRA Outcome Software, Inc.
THIS JOB HAS EXPIRED Description
Outcome, 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.
Preferred location is Outcome headquarters in Cambridge, MA but will consider home based location.
The Principal CRA at Outcome participates in the planning, design and execution of post marketing approval registry studies to ensure all studies are conducted according to the intent of the client/sponsor while adhering to regulatory guidelines, SOPs, GCP (where applicable) and registry protocols while working collaboratively with internal and external project team members with the ability to manage complex/international studies. Has the ability to independently perform on-site monitoring visits in addition to supporting co-monitoring visits. 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 contract CRAs, and mentors CRA Is and Clinical Research Assistants. Proactively identifies and escalates or resolves operational project issues and participates in process improvement initiatives as required.
Lead 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.)Act as site liaison to CRAs/Project Managers
Serve as a clinical resource for sites, Project Managers, Clinical Data Managers, contract Clinical Research Associates, and other Outcome staff for project-related inquiries and issues; conduct initial and ongoing site, sponsor, and project staff training as necessary
Participate regularly in client calls; provide updates on study reports (site, enrollment, regulatory document, query, monitoring status, etc.); assist the client in problem solving and provide consultation on study-related activities where applicable
Manage and track study progress on recruitment/site selection, site readiness, IRB/EC submissions, patient enrollment, etc.
Utilize internal databases to manage and track site/client contacts, patient enrollment, and other registry-specific reports, and provide reports to Project Management/CRAs/client in a timely manner
Ability to understand and contribute to EDC and PCMS specifications, database requirements, customizations, queries/form controls
Perform comprehensive trainings on the protocol and the company's EDC for sites (web-based), clients and internally to the team
Primary contact for all site interactions (phone and email support) involving the company's EDC by addressing clinical and protocol-related questions
Maintain correspondence with sites to ensure compliance with study procedures, assess patient accrual, applicable regulations and ICH/GCP (if applicable), and has the ability to recognize and escalate issues where appropriate
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
Ability to prepare appropriate, timely and accurate communication to internal and external registry teams, consultants and investigative site personnel
Mentor and train less experienced Clinical Study Assistants and less experienced Clinical Research Associates
Participate in remote monitoring and data quality audits
May be required to conduct independent on-site visits (Qualification, Initiation, Interim, Close-Out) to monitor study progress and assure compliance with protocol-requirements, applicable regulations and ICH/GCP (if applicable), ensures Investigator Site File is up to date; assist site with IRB/EC submissions; generate monitoring visit reports, confirmation and follow-up letters; identify and solve or escalate problems/issues where appropriate
May function as Lead CRA; possess the ability to oversee, train, and coordinate contract CRAs and junior level staff worldwide as appropriate; including review of monitoring reports and tracking monitoring activities
May perform other duties as applicable
May participate in site contract negotiation and budgeting within approved parameters
May include participation in financial budget management , bid defense meetings, and formulating strategic solutions to ensure study success (i.e., contingency plans, recruitment strategies, patient retention strategies, site/patient incentives, collaborate/interact with KOLs)
May include 5 - 25% travel, to attend Investigator Meetings, Site Visits, and Professional Conferences
Bachelors Degree, preferably in a health or life science concentration
At least 3 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a preferred minimum of 2 years of independent clinical monitoring
Must be detail oriented, enthusiastic, eager, and have a strong customer service sensibility
Excellent time management and decision making skills
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
Ability to take initiative
Excellent verbal, written communication and interpersonal skills
Must be proficient in Microsoft Office
Must have professional demeanor
Experience with Electronic Data Capture (EDC) preferred
Understanding of GCPs and knowledge of regulatory requirements
Willingness and flexibility to travel; this position may require national and/or international travel on a need by basis
||Cambridge, MA |
THIS JOB HAS EXPIRED