Senior In House Clinical Research Associate (CRA) Job
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POST DATE 8/25/2016
END DATE 10/11/2016
JOB DESCRIPTIONAPPLY Requisition ID 42243BR
Title Senior 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. May be responsible for monitoring assigned sites in accordance with GCP/ICH and NNI SOPs.
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.
- 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 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 drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements.
- Liaises with Business Management to secure confidentiality agreements, master services agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight approval.
- Monitors recruitment remotely through IVRS and EDC systems/communication with sites.
- Preparation and review of various study related tracking systems to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB, etc.) and 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 green light packages to the Quality Management Group within CTM for approval.
- 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.
- May provide active mentorship of CTM staff to build talent across the department.
- May support in the identification of training needs, the development of training materials to meet those needs, and provide training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures.
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams, contributor to CORE Team Meetings.
- Participates in cross-functional teams, locally, to assure timely attainment of project milestones.
- Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to ensure that the mandatory trial entries are made in IMPACT, ClinTrack, novoDOCs, EDC administration, and updates are made.
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.
- Attend relevant symposia, conferences and scientific meetings, as necessary.
- Provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.
- Approximately 50% overnight travel to visit assigned sites for monitoring and/or for attendance at meetings and trainings.
- Office based in Plainsboro, NJ.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelor s degree required (science-related discipline preferred).
- A minimum of 1 year of site monitoring experience required.
- A minimum of 3 years of direct expertise of site management and logistical execution of clinical trials required.
- A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting required; some experience in area of specialty preferred.
- Demonstrated computer skills (MS Office, MS Project, MS PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
Department CMR - SITE MANAGEMENT (1c)
Position Location US - Princeton, NJ
State/Provinces US - NJ
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line