Clinical Research Scientist
Responsibilities will include, but are not limited to, the following:
1. Assist the Clinical Research Physician to interface with project team members including: Clinical
Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
4. Clinical study report preparation
5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
6. Participate in Development Planning for assigned compounds.
7. Oversee and challenges the adequacy of planning for study implementation
8. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
9. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
10. Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
11. Collaborates and supports operational activities as need be.
12. Assist in establishing project budgets
13. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
14. Participate and present at investigator meetings
15. Participate in adhoc meetings (e.g. marketing)
16. Assist in document template design and SOP writing
17. Participate on various corporate committees
18. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required
19. Lead team meetings as required
Qualifications
Qualifications
Prerequisite:
Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field),
Skills/Knowledge Required:
• Minimum 2 yrs. experience in medical or technical writing
• Clinical monitoring experience preferred
• Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
• Extensive medical/scientific and clinical research knowledge
• Knowledge of Medical Terminology
• Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
• Proficient at data interpretation
• Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
• Experience in all aspects of the drug development process
• Knowledge of GCP and ICH Guidelines
• Experience in presenting at Investigator Meetings
• Detail-oriented, well-organized
• Limited travel required
• Ability to assimilate technical and scientific information quickly
• Clinical project management skills
• Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus
• Demonstrated ability to work as part of a team
• High level of interpersonal and communication skills (written and verbal)
Additional Information
All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP!
I look forward to hearing from you!