Clinical Scientist
American Cybersystems, Inc.

Job Info

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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.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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