Senior Clinical Research Associate - Northeast- Remote

254125BR
Senior Clinical Research Associate - Northeast- Remote
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

We are Novartis. Join us and help reimagine medicine.

The Senior Clinical Research Associate will serve as a leader and mentor other CRAs in all aspects of the CRA role. This position will report to the Regional Associate Director(RAD).

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 a reference to other CRAs on electronic systems.
May be 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.).

Meeting of study milestones including study start-up and recruitment timelines. Delivery of high quality data according to agreed timelines following international and local regulations and Novartis SOP standards. Quality and timeliness of: updating the Novartis electronic systems, monitoring reports, and communication efforts. Deliver customer satisfaction results for internal and external customers. Collaborate with US Clinical Development & Medical Affairs (CD&MA) and Field Medical to identify, develop and support sites and to achieve trial objectives. Completion of extra assignments beyond responsibilities. Local individual KPIs as determined by Head of US ICRO and US CD&MA Head.

This position will cover the Northeast territory. Preferred location is Boston or New York
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 in a scientific or health care discipline required, and advanced degree preferred. A nursing qualification or extensive relevant experience may commensurate.
Solid medical and business knowledge.
Minimum of three years of experience as a CRA.
Trial Lead CRA experience desirable.
Oncology experience preferred
Demonstrated ability to coordinate, organize, communicate, and manage 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.
Computer literacy and proficiency.
Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines.
A valid US Driver’s License and a good driving record are required.
Ability to travel within the territory, approximately 30%

This is a remote based position.
Global Drug Development
GDO GDD
USA
Boston, MA
Novartis Pharmaceuticals
Research & Development
Full Time
Regular