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Requisition ID 32618BR
Title In-House Clinical Research Associate (CRA)
Job Category Clinical Trial Management
Job Description PURPOSE:
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations and SOPs. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR.
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.
COORDINATION/COMMUNICATION, ADMINISTRATION & PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
- May participate in continuous improvement processes for function.
- 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.
- Act as primary liaison for assigned study sites to convey project information and answer questions 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 LCRA to ensure that Corrective Action Plans (CAP) with investigative sites are overseen.
- Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
- Attends Investigator Meetings and study-specific training for assigned trials
- Collaborates with the LCRAs 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 LCRAs and/or FCRAs 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.
- Liaises with Business Management to secure confidentiality agreements, master service agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight approval...cont.