Clinical Research Scientist (Inflammation & Immunology) Job

CLINICAL RESEARCH SCIENTIST, INFLAMMATION & IMMUNOLOGY needed for a CONTRACT opportunity with Warren, NJ.

Top Skills Should You Possess:
- Clinical research knowledge
- Medical/technical writing

What You'll Be Doing:
- Reviews data listings, monitors adverse event and concomitant mediation reporting for study subjects. Utilizes and reviews clinical trial data on a daily basis in RAVE, INFORM, CDRP listings, and other tables, graphs and listings using study related monitoring programs.
- Prepare key documents for Investigator Brochures ("IB"), regulatory submission documents, internal/external presentations, and related documents to support clinical research and drug development for Inflammation & Immunology therapeutics.
- Prepare protocols and guidelines, including writing, reviewing, amending and cross-functional facilitation as appropriate, and collaborating with Key Opinion Leaders as required.
- Prepare and review clinical study reports in order to determine potential drug indicators and clinical development plans.
- Collaborate with the project physician to direct the planning and implementation of clinical programs to meet corporate and clinical research goals.
- Provide clinical research expertise in the guidance and recommendations to Clinical Research Physicians in the management of ongoing projects.
- Collaborate and support operational objectives as needed. Assist in establishing Standard Operating Procedures, and reviewing ongoing study data including: safety, primary efficacy variables, and laboratory data.
- Plan, participate and present at investigator meetings and ad-hoc meetings.
- Prepare DMC and/or SMT safety presentations. Prepare deliverables for periodic review meetings and participate, eg Study Management Team
- Provides Clinical Management with regular study updates/status reports on study data
- Perform other tasks as assigned by supervisor

What You Need to Bring to the Table:
- Minimum one to three (1-3) years experience with medical or technical writing
- Experience with INFORM, RAVE, J-Review and clinical trial databases
- Extensive medical/scientific and clinical research knowledge
- Advanced analytical and influencing skills
- Knowledge of early and late phase clinical program development
- Proficient at data interpretation
- Expert understanding of global clinical study design and drug development processes
- Knowledge of GCP and ICH Guidelines

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: SCIENTIFIC; J2W: CLINICAL

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