Principal Clinical Research Associate
Location: Cambridge Massachusetts
Description: Summit Recruiters is at present recruited Principal Clinical Research Associate right now, this job will be placed in Massachusetts. More details about this job opportunity kindly read the description below. Senior/Principal Clinical Research Associate
Located in Cambridge, MA weare developing, manufacturing and commercializing medical devices that enable in vivo patholo! gy. Initial products will integrate breakthrough optical imaging technologies with advanced algorithmic processes to provide physicians with real-time decision making capabilities and image-guided therapies during minimally invasive procedures. The Companys vision is to provide products that ultimately streamline care and improve patient outcomes.
General Summary:
We are seeking a senior-level CRA for the Companys Clinical Affairs Department, which will be under some supervision of the Director of Clinical Affairs. This position participates in the planning, designing, and executing of high quality clinical trials to ensure safety and effectiveness of NPM products. The candidate will work with confidential patient and company data, and interface with a variety of internal and external stakeholders. This position will be involved in the monitoring of NPM clinical trials. This role must assure investigational site compliance with clinical trial protocols, ! SOPs, GCP and FDA regulations.
Requirements:
Monitors clinical trials and manages clinical sites for compliance with trial requirements, NPM SOPs, GCP and FDA regulations within the timelines required by NPM management. May oversee multiple protocols with a variety of investigational centers. Works with members of the NPM Clinical Affairs Department to monitor compliance with Monitoring Plan for all trials. If needed, may be required to conduct site visits outside the United States to ensure compliance with the plan and meet trial timelines.
Assure proper conduct of the trial; quality, and accuracy and complete reporting of clinical events and data by the investigational sites. Takes initiative in identifying project-specific site training needs to assure site compliance.
Initiates investigational sites and performs ongoing training on trial and regulatory requirements related to the conduct of a clinical tri! al and the investigator obligations through monitoring visits, query resolution and deviation reporting.
Accurately reports documents and files for all relevant investigational site visits and activities within the timelines required by NPM management.
Contributes to the implementation of clinical trials by assisting the team in developing and reviewing trial-specific documents and manuals necessary to the conduct of the trial, including case report forms, subject visit worksheets, and monitor tools.
Independently troubleshoots issues and makes decisions within project assignments.
Adapts to changing priorities and independently motivates self and others to complete tasks in an accurate and timely manner.
Assists with the development, negotiation, and execution of the site contract, budget and payment plan, with final approval from Clinical management.
Assists with development, approval, and distribution of study-related documents including Case Repo! rt Forms (CRFs), study protocols, study manuals, and other study tools ! to investigational sites and review committees.
Drafts informed consents.
Gathers documents and information for clinical investigator and laboratory selection.
Manages device accountability, inventory, and distribution. Manages the oversight of device complaint/malfunction process and tracking.
Prepares and participates in presentation of protocols and other study conduct requirements at study initiations at investigational sites when needed.
Oversees subject screening and enrollment at assigned clinical sites.
Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness.
Tracks and reports progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQs. Assists in query writing and resolution process, as required. Identifies and gathers missing or incomplete data from the investigational sites. !
Provides mentoring to junior staff, as the Clinical Affairs Department grows, regarding protocols, site management, GCP, FDA regulations, etc.
Assists clinical project team with developing/maintaining project timeline, managing study budget, and preparing routine operations reports.
Coordinates Clinical staff in the oversight of site compliance including the development and implementation of corrective actions for addressing noncompliance issues.
Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOPs and Work Instructions.
Education Requirements:
Bachelors-level degree required. Degree in science/health related field (e.g., Biology, Nursing, etc.) preferred.
Association for Clinical Research Professionals (ACRP) Professional Certification (CCRA) a plus
Proficiency in computer skills Strong communication and organizational skills
Knowledge and experience of ICH GCP guid! elines and FDA 21 CFR 812
Demonstrated knowledge of scientific meth! odology in design and conduct of clinical research
Demonstrated ability to motivate, persuade, and educate site personnel
Ability and willingness to share knowledge with teammates
Excellent record retention, time management, decision-making, customer service, and interpersonal skills
Ability to work independently with minimal supervision
This is an in-house position. Travel up to 50% at times may be required. International travel may be required at times.
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Summit Recruiters.
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This job starts available on: Mon, 24 Jun 2013 06:24:26 GMT