Pacira Pharmaceuticals, Inc Clinical Trial Associate in Parsippany, New Jersey
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
The purpose of this position is to provide support for the planning, execution, and financial aspects of Phase I IV clinical studies and other tasks completed to ensure the objectives of the studies are met.
* Assist the Clinical Trial Managers with achieving key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, study execution, data collection, and close-out.
* Assist in the preparation of study documents including, but not limited to, clinical protocols and amendments, case report forms and source document templates, informed consent forms, site training materials, site regulatory binder, site pharmacy binder, and clinical study reports.
* Assist in the day-to-day operational activities and other specific projects as assigned within Clinical Operations.
* Accountable for the maintenance of the electronic Trial Master Files (TMF) in accordance with SOPs
* Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines.
* Accountable to develop and review regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits
* Act as primary liaison for study sites and monitors to convey project information and answer questions in accordance with the CTM escalation pathway
* Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of clinical trial documentation.
* Attends Investigator Meetings and study-specific training for assigned trials
* Collaborates with the monitors to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics.
* Responsible for communicating issues in accordance with the CTM escalation pathway to the monitors as appropriate.
* Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for patient safety and regulatory compliance for all assigned sites.
* Ensures all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned monitor.
* Liaises with Procurement, Legal and Finance to secure confidentiality agreements, master service agreements, clinical trial agreements as appropriate.
* Monitors recruitment remotely through IRT and EDC systems and/or communication with sites
* Prepares and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.)
* Responsible for the follow up to collect outstanding documents
* Provides quality overview and consistency check on all developed ICFs and completes the informed consent checklist
* Responsible for the submission and correction of regulatory packages for drug release to the CTM for approval.
* Responsible to assure adequate and appropriate dissemination of information according to the clinical study plan between sites and clinical project team staff to ensure project success.
* Responsible to coordinate and secure IRB approval (local and central).
* Responsible to provide step by step guidance and partnership with sites to secure IRB approval
* Understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
* Bachelor s degree from an accredited college or university or equivalent experience required.
* 3 years of closely related health sciences experience; pharmaceutical industry experience is preferred; experience in the areas of clinical operations and/or project management a plus.
* Demonstrated knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with medical terminology is necessary
* Proven ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment.
* Proficiency using Microsoft Outlook, Word, Excel and PowerPoint.
* Excellent oral and written English communication skills.
* Experience in various electronic data capture systems involving site enrollment and tracking is a plus.
Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.
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