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Posted: Saturday, February 3, 2018 6:32 PM

Requisition ID 52894BR
Title Senior Clinical Research Associate InHouse Site Management
Job Category Clinical Development
Job Description
Multiple Positions
Purpose
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations and Standard Operating Procedures (SOPs). Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical Medical Regulatory (CMR). May be responsible for monitoring assigned sites in accordance with GCP/ICH and Novo Nordisk Inc. (NNI) SOPs.
Relationships
Reports to a Manager/Senior Manager/Associate Director of Site Management (SM) within CTM. Accountable for actively participating in multiple internal cross:functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.
Essential Functions
Coordination/Communication, Administration and Personnel Development: Ensure compliance with the application and communication of all Novo Nordisk(R) policies, procedures and fundamentals.
Functional Support: May participate in continuous improvement processes for function.
Project Support: Accountable for the maintenance of the electronic Trial Master Files (TMF) in accordance with NNI SOPs. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with NNI 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. Acts as primary liaison for assigned study sites to convey project information, answer questions and in accordance with the CTM escalation pathway. Arranges for certified translation of study documentation as appropriate. Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of clinical trial documentation. May collaborate with FCRA and/or Lead Clinical Research Associate (LCRA) to ensure that Corrective Action Plans (CAP) with investigative sites are overseen. Attends Investigator Meetings and study:specific training for assigned trials. Collaborates with the Lead CRA(s) to obtain/share trial specifics 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 Lead CRA(s) and/or CRAs 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 FCRA. If assigned monitoring activities, acts as primary liaison for assigned study sites while on:site to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues. If assigned monitoring activities, completes follow up letters from all visit types according to SOPs and completes reports to quality standards within company specified timelines. If assigned monitoring activities, may be responsible for maintaining current Investigator Trial File (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines while on site. If assigned monitoring activities, may complete Site Selection, Site Initiation, Routine Monitoring and Close:out Visits according to SOPs and completes reports to quality standards within company specified timelines. If assigned monitoring activities, may perform on:site dru

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• Location: Jersey Shore

• Post ID: 53556677 jerseyshore
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