US-NJ, Senior Clinical Research Scientist 210800BR-MZ
Senior Clinical Research Scientist
East Hanover, NJ
Research & Development
The Senior Clinical Research Scientist (SCRS) will support US efforts in the planning, execution and reporting of US CD&MA clinical trials in Oncology/Hematology/Rare Disease/Early Therapeutics.
1. Responsible for the implementation of designated clinical trials including investigator selection, patient recruitment, preparation of trial related documentation (protocols, Case report forms, consent documents, letters of agreement, confidentiality agreements), and organizing Ethics committee submissions. Track and manage key trial indictors including: monthly project status, key deliverables to senior management. Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems.
2. Serve as U.S. Local trial lead for multiple global clinical development trials and/or non-registration U.S. Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use). Interface with the oncology therapeutic area global and U.S. clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas
3. Liaise with study investigators, site research staff, and field based colleagues to support clinical studies. Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.
4. Organize investigator s start-up meeting and study site initiation meetings.
5. Drive study enrollment, plan advisory boards, and perform external study feasibility with investigators.
6. Patient Recruitment: track enrollment, develop recruitment plans, and ensure procedures are in place for appropriate optimization of patients into the clinical trial. Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
7. Understand and comply with company SOPs and GCP s; contribute to continuous improvement in SOPs and local Working Practices.
8. Plan the requirements for clinical trial (CT) material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby material is shipped to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary.
9. Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used.
10. Contribute to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency.
11. Support the development, management and tracking of trial budgets working closely with the appropriate partners.
12. Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
13. Manage the Contract Research Organizations initial identification of a suitable partner, definition of CRO responsibilities, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success.
14. Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with.
15. Support all scientific aspects of clinical trial(s) and program level activities as assigned.
16. Provide management to the clinical research scientists to ensure that their role and contribution is optimized. Lead a cross functional team.
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.
Conducts above activities with some oversight and direction, ability to work independently and give some direction to others. Mid-level competency for above activities, no managerial responsibilities.
Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.
Significant clinical research or research monitoring experience (comparable to 3 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.
In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.
Effective clinical monitoring skills.
Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures.
Ability to mentor and train other monitors in a positive and effective manner.
Ability to evaluate medical research data and proficient knowledge of medical terminology.
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
Strong customer focus.
Excellent interpersonal skills.
Strong attention to detail.
Effective organizational and time management skills.
Proven flexibility and adaptability.
Excellent team player with team building skills.
Ability to work independently as required.
Ability to utilize problem-solving techniques applicable to constantly changing environment.
Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software.
Good English language and grammar skills.
Effective presentation skills.
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