In-House Clinical Research Associate

Organization
Novo Nordisk
Job Location
Princeton, NJ
Job Description

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 Clinical Development, Medical & Regulatory Affairs (CMR) department.

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 & 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 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 Field CRA and/or Lead CRA 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 Lead CRAs and/or Field 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 Field CRA
* 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
* Monitors recruitment remotely through IVRS 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 green light packages to the Quality Management Group within CTM for approval
* Responsible to assure 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 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

STAFF DEVELOPMENT:
* May provide active mentorship of CTM staff to build talent across the department
* May provide 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:
* Active membership to local project teams. Contributes to CORE Team Meetings
* Participates in cross-functional teams, locally, to assure timely attainment of project milestones
* Responsible for the compliance and quality of CATS reporting for self
* 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 ensure updates are made
* Responsible to maintain focus, locally, for specific project activities within CMR priorities

TRAINING:
* Attend relevant symposia, conferences and scientific meetings, as necessary
* May identify training needs across CTM and provide support of the creation, development and/or training to meet those needs
* This includes any lessons learned sharing across the project team members and/or CTM

PHYSICAL REQUIREMENTS:
* Approximately 20% overnight travel for meetings and/or trainings
* Office Based in Princeton, NJ

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
* A Bachelor’s degree is required, preferrably in a science-related discipline
* A minimum of two (2) years’ of direct expertise of site management and logistical execution of clinical trials within a pharmaceutical, biotechnology, CRO and/or healthcare setting required
* Must have demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
* Must have the ability to demonstrate core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
* Must have knowledge of GCP as relates to clinical trial management

Department CMR - SITE MANAGEMENT IHCRA (3)
Position Location US - Princeton, NJ
City Princeton
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 principle – helping us find the right balance between compassion and competitiveness

With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!

Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information...cont.

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