US-KY, Senior Clinical Research Associate (Louisville, KY or Indianapolis, IN 219855BR-MZ
Senior Clinical Research Associate (Louisville, KY or Indianapolis, IN
Global Drug Development
Research & Development
Support the goals of the GenMed 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 Oncology clinical trial related activities. Mentor to CRAs. Trial Lead CRA role for a trial when assigned.
1. Serve as a leader and mentor to other CRAs in all aspects of the CRA role. 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.
2. Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification.
3. 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.
4. 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.
5. 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.
6. Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return.
7. 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 a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems.
8. Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.).
9. Enforce and follow GCP and ICH requirements as appropriate.
10. Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations. May review and approve monitoring reports of junior CRAs as assigned.
11. Manage data query resolution process with sites and track status updates (i.e. IWS).
12. Perform Site Closeout activities per SOPs and applicable regulations.
13. Travel domestically (and possibly internationally) as needed to study sites and for training and meetings. A minimum of 50% overnight travel may be required.
14. Attend and participate in disease indication and project specific training and general CRA training as required.
15. Perform additional roles and functions for GenMed Clinical Operations as assigned such as a trial Lead CRA, systems superuser, or committee member.
16. Support the successful implementation of innovative processes and technologies.
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.
Bachelor s degree or higher in a scientific or health care discipline preferred. A nursing qualification or extensive relevant experience may commensurate.
Fluent English (oral and written).
1. Solid medical and business knowledge.
2. Three to five years of experience as a CRA. Trial Lead CRA experience desirable.
3. Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team.
4. Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations.
5. Excellent oral and written communication and presentation skills.
6. Computer literacy and proficiency.
7. Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines.
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