Apex Systems Inc
- Strong collaboration with cross functional team members
- Scheduling and facilitating protocol review meetings
- Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
- Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
- Partecipate in ad hoc meetings
- Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
- This position will require strong scientific writing skills and leadership to drive the development of Acute Myeloid Leukemia trials
- Oversee and challenges the adequacy of planning for study implementation
- In collaboration with the clinical research physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
- Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
- Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
- Collaborates and supports operational activities as need be
- Assist in establishing project budgets
- Assist with review of ongoing summary hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
- Review of Work directly into the clinical database to post and resolve queries with the sites.
- Adhere to standard operating procedures, protocols, and study specific guidelines
- Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field)
- Minimum 5 years experience in clinical research development
- Protocol writing experience is required
- Minimum 2 yrs experience in oncology/hematology clinical development
- Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
- Experience with electronic data bases (EDC, RAVE, JReview etc)
- Knowledge of clinical trial design, basic statistics, and data review tools
- Proficient at data interpretation
- Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
- Full understanding GCP and ICH Guidelines
- Detail-oriented, well-organized
- Ability to assimilate technical and scientific information quickly
- Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus),
- Demonstrated ability to work as part of a team
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resum] or ************.
Apex Systems Inc
Website : https://www.apexlifesciences.com/
Apex Life Sciences is a division of the 3rd largest clinical/scientific staffing and services firm in the U.S. We match top scientific, engineering, and clinical research professionals at all career levels for contract, contract-to-hire, and direct hire opportunities.