US-CA, Expert Clinical Research Associate 218866BR-MZ
Expert Clinical Research Associate
Global Develop NPH
San Francisco, CA
Research & Development
Support the goals of the Gen Med organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Novartis SOPs and ensuring that study milestones are met. Central point of communication between Novartis and investigational sites for all clinical trial related activities. Mentor to CRAs. Trial Lead CRA role when assigned. Performs additional roles and functions for US ICRO as assigned; such as participating/leading special project initiatives and committees. Is an essential contributor for the assessment and development of processes.
Serve as a thought leader and expert on monitoring processes, procedures, and systems to other CRAs. May represent RAD and region at Management Meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g. site selection, site issue resolution). May interview prospective CRA candidates and assist with performance evaluation and management of CRAs.
Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification.
Ensure the site Investigator Folder is up to date and mirrors the Novartis TMF. Responsible for collecting regulatory documents from site and filing in the Novartis TMF. Prepare and collect study site documents.
Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE reporting, GCP, and possibly the drug mechanism.
Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials. Nominate sites to participate in studies in conjunction with Medical Science Liaison (MSL) and Clinical Research Medical Advisor (CRMA) colleagues.
Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return.
Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as an expert to other CRAs on electronic systems. Responsible for assisting with the evaluation, design and implementation of new systems.
Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.).
Enforce and follow GCP and ICH requirements as appropriate.
Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations. May review and approve monitoring reports of other CRAs as assigned.
Manage data query resolution process with sites and across trial and track status updates.
Perform Site Closeout activities per SOPs and applicable regulations.
Key Performance Indicators:
Meeting of study milestones including study start-up and recruitment timelines.
Ensuring the delivery of high quality data (from individual sites and teams when LCRA) according to agreed timelines following international and local regulations and Novartis SOP standards.
Highest quality and timeliness of: updating the Novartis electronic systems, monitoring reports, and communication efforts.
Deliver customer satisfaction results for internal and external customers.
Mentoring and leading internal and external teams.
Collaborate with US CD&MA and Field Medical to identify, develop and support sites and to achieve trial objectives.
Completion of extra assignments beyond responsibilities and execution of expectations.
Local individual KPIs as determined by Head of US ICRO and US CD&MA Head
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelors degree or higher in a scientific or healthcare discipline preferred. A nursing degree or extensive relevant experience may commensurate.
Understanding of medical and business knowledge relevant to clinical trial execution.
Eight to ten years of CRA experience.
Solid understanding of clinical trial design, trial ex-ecution, and operations.
Trial Lead CRA experience.
Demonstrated ability to coordinate, organize, communicate, and manage trial site activities, with knowledge of when to escalate issues to management or clinical team.
Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations.
Excellent oral and written communication and presentation skills.
Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines.
Computer literacy and proficiency.
Experience as a CRA mentor.
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