Position type: Full-time contract
Duration: 12 Months
Location: Princeton Pike, NJ, Madison, NJ or Brisbane, CA (Onsite)
As a Clinical Scientist, you will:
The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
• Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.
• May lead or support trial level activities for one or more trials with the necessary supervision.
• Collaborate and liaise with external partners (e.g., KOLs).
• Seek out and enact best practices with instruction.
• Provide regular and timely updates to manager/management as requested.
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
• Conduct literature review.
• Develop site and CRA training materials and present these at SIVs and Investigator meetings.
• Review clinical narratives.
• Collaborate cross-functionally to monitor clinical data for specific trends.
• Contribute to the development of Data Review Plan in collaboration with Data Management.
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
• Submit clinical documents to TMF.
• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
• Expectation of 2+ years of experience in clinical science, clinical research, or equivalent.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
• Ability to understand assigned protocol(s) and their requirements.
• Knowledge and skills to support program-specific data review and trend identification.
• Intermediate medical writing skills and medical terminology.
• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
• Basic planning/project management skills (develop short range plans that are realistic and effective)
• Basic knowledge of disease area, compound, current clinical landscape.
• Detail-oriented with commitment to quality
• Intermediate critical thinking and problem-solving skills.
• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools)
Domestic and international travel may be required (approximately 10-20%)
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
Thank you!
Sankalp Agnihotri
Associate Recruiter
PAY RANGE AND BENEFITS:
Pay Range*: $70.00 - $77.80 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
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