Senior Clinical Research Associate In House Site Management Job job in Princeton
|Employer:|| Novo Nordisk Inc.|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, federal regulations and Standard Operating Procedures (SOPs). Collaboration with members within North America Clinical Trials (NACO) and various representatives in Clinical Medical Regulatory. May be responsible for monitoring assigned sites in accordance with GCP/ICH and Novo Nordisk Inc. (NNI) SOPs.
Reports to a Manager/Sr. Manager/Associate Director of Site Management within NACO. Participate in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or 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 documentation files and compliance with NNI SOPs, GCP and ICH Guidelines. Accountable to develop and review regulatory documentation to support study start up activities, ensuring all site supplies are available on site for site initiation visits. Primary liaison for assigned study sites to convey project information, answer questions and in accordance with the NACO escalation pathway. Arranges for certified translation of study documentation as appropriate. Assists project team in preparation for audits/inspections and responsible for the quality and completeness of clinical trial documentation. May collaborate with Field Clinical Research Associate (FCRA) and/or Clinical Site Lead (CSL) to ensure that Corrective Action Plans (CAP) with investigative sites are overseen. Attends Investigator Meetings and study-specific training for assigned trials. Collaborates with CSL/CRAs 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 NACO escalation pathway to the CSL/CRAs as appropriate. Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for patient safety and regulatory compliance for assigned sites. Ensures regulatory documents and study supplies are maintained during the lifecycle of 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 NACO escalation pathway to the CSL to resolve site related issues. Would also complete follow up letters from all visit types according to SOPs and completes reports to quality standards within specified timelines. Additionally, may be responsible for maintaining current Investigator Trial File (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of 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. Liaise with Business Management to secure confidentiality, master services, and clinical trial agreements as appropriate and use information to prioritize sites for Greenlight approval. Monitors recruitment remotely through Interactive Voice Response System (IVRS) and Electronic Data Capture (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 documents as protocol, Investigator Brochure (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 submission and correction of regulatory green light packages to the Quality Management Group for approval. Responsible to coordinate and secure Institutional Review Board (IRB) approval (local/central). Responsible to provide 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 NACO staff to build talent across the department. May support in identifying training needs, developing training materials to meet those needs, and providing training as required to improve core competency and skill set of staff. May support the maintenance of guidelines, training programs, policies and procedures.
Team coordination: Accountable for the compliance and quality of Cross Application Timesheets 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. Will conduct self 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 maintain focus, locally, for specific project activities within NACO priorities.
Training: Attend relevant symposia/conferences/scientific meetings, as necessary. Provide support of training needs across NACO 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 NACO.
40-50% overnight travel required.
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290 . This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Requisition ID: 58019BR
Job Category: Clinical Development