Requisition ID 18237BR
Title In-House Clinical Research Associate (CRA)
Job Category Clinical
Job Description PURPOSE:
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. 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.
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® policies, procedures and fundamentals.
FUNCTIONAL SUPPORT:
May participate in continuous improvement processes for function.
PROJECT SUPPORT:
- Accountable for the setup, quality and 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 provide develop regulatory documentation to support study start up
activities, including all site supplies.
- Act as primary liaison for assigned study sites to convey project information, answer
questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues.
- 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 in-house documentation.
- Attains thorough understanding of study management tasks and responsibilities
necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
- 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 CRAs as appropriate.
- Ensure all regulatory documents and study supplies are maintained during the
lifecycle of any assigned project in collaboration with the assigned CRA.
- Liaises with Clinical Budget Management to secure confidentiality agreements, master
services agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight approval.
- 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 for assuring adequate and appropriate dissemination of information
according to the study specific communication plan between sites, in house and regionally based staff to ensure project success.
- Responsible for coordinating and securing IRB approval (local and central).
- Responsible for providing 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.
STAFF DEVELOPMENT:
- May provide active mentorship of CTM staff to build talent across the department.
- May support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams, contributor to Clinical Team Unit (CTU) Meetings.
- Participates in cross-functional teams, locally, to assure timely attainment of project
milestones.
- Responsible for conducting oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible for ensuring that the mandatory trial entries are made in IMPACT,
NovoDOCs, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible for maintaining focus, locally, for specific project activities within CMR
priorities.
TRAINING:
- 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.
PHYSICAL REQUIREMENTS:
- Approximately 20% overnight travel to visit assigned sites for monitoring and/or trainings office.
- Based in Princeton, NJ.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree required (science-related discipline strongly preferred).
- A minimum of 5 years of clinical trial experience within pharmaceutical, biotechnology, CRO company and/or healthcare setting.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Direct expertise of site management and logistical execution of clinical trials for at least 2 years.
- Knowledge of GCP as relates to clinical trial management.
- Previous on-site monitoring experience preferred.
Department CMR - SITE MANAGEMENT (1b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NH
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%