US-KS, Clinical Research Associate (Kansas City, MO) 216981BR-MZ
Clinical Research Associate (Kansas City, MO)
Global Drug Development
Kansas City, MO
Research & Development
Support the goals of the 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.
1. Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification.
2. 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.
3. 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 re-porting, GCP, and possibly the drug mechanism.
4. Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials. Nominate sites to participate in studies in con-junction with Medical Science Liaison (MSL) and Clinical Research Medical Advisor (CRMA) colleagues.
5. Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return.
6. 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).
7. Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.).
8. Enforce and follow GCP and ICH requirements as appropriate.
9. Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations.
10. Manage data query resolution process with sites and track status updates (i.e. IWS).
11. Perform Site Closeout activities per SOPs and applicable regulations.
12. Travel domestically (and possibly internationally) as needed to study sites and for training and meetings. A minimum of 50% overnight travel may be required.
13. Attend disease indication and project specific training and general CRA training as required. May participate in the training of other CRAs at meetings.
14. Perform additional roles and functions for Clinical Operations as assigned such as a Trial Lead CRA, systems superuser, or committee member.
15. Support the successful implementation of innovative processes and technologies.
Key Performance Indicators:
1. Meeting of study milestones including study start-up and recruitment timelines.
2. Ensuring the delivery of high quality data according to agreed timelines following international and local regulations and Novartis SOP standards.
3. Quality and timeliness of: updating the Novartis electronic systems, monitoring reports, and communication efforts.
4. Deliver customer satisfaction results for internal and external customers.
5. Collaborate with US CD&MA and Field Medical to identify, develop and support sites and to achieve trial objectives.
6. Completion of extra assignments beyond responsibilities
7. 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.
Education (minimum / desirable): Bachelor s degree in a health care or scientific discipline preferred. A nursing qualification or extensive relevant experience may commensurate.
Languages: Fluent English (oral and written).
Experience / Professional requirement:
1. Up to 2 years of prior experience in a clinical research role as either a CRA or site CRC or relevant experience.
2. Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to Management or Clinical Team.
3. Understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations.
4. Proven ability to work on teams and deliver on
5. Computer literacy and proficiency.
6. Strong oral and written communication and presentation skills.
7. Ability to multi-task and prioritize multiple high-priority projects, site questions, and clinical team inquiries while managing responsibilities and deadlines.
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