Clinical Research Scientist Assistant - Medical School Gap Year Program Job|
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||Nov 15, 2017
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||US - New Jersey - Summit
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Medical School Gap Year Program (MSGYP) is a 2-year post baccalaureate program for pre-medical students designed to provide training opportunities and meaningful work experiences during the “gap” or “bridge” year before attending medical school. Highly-talented graduates will gain hands on clinical development experience and increase their competitiveness for top MD programs. Students will perform independent work with a dedicated scientific/medical mentor and be involved in the development and conduct of a clinical trial collaborating with our worldwide teams (i.e. translational medicine, clinical operations, regulatory affairs, health outcomes research, etc) throughout the stages of the drug development process.
Purpose of MSGYP:
Introduce pre-medical students to the drug development process and physician career paths within the pharmaceutical industry.
Ideal Candidate for MSGYP:
We are looking pre-medical students graduating at the top of their class (minimum 3.25/4.0 GPA). Candidates need to be well rounded and enthusiastic about Celgene and the pharmaceutical industry, a self-starter with high ambition.
Components of MSGYP:
The CR&D MSGYP candidate will function as an assistant Clinical Research Scientist (CRS) and focus on the science and strategy of drug development. The participant will learn various aspects of global clinical studies (Phases I-III) including start-up, maintenance and close-out activities in collaboration with the Clinical Research Physician (CRP) and the cross-functional study team.
Objectives for MSGYP:
- Understand the principles and key foundations of clinical trial development and how they relate to the overall drug development process (i.e. randomization/stratification, control, blinding, selection of population, schedule of assessments, and study endpoints)
- Attain a working knowledge of Good Clinical Practices and International Conference on Harmonisation (ICH) guidelines in relation to clinical trial conduct and sound patient-focused practices
- To understand the role of the Clinical Research Physician (CRP)
- Work closely with the CRP and study team in making study-specific recommendations, providing clinical research expertise, presenting protocol-specific topics, and supporting the team at various therapeutic area conferences
- Gain extensive hematology/oncology therapeutic area and product-related expertise as well as engage in scientific/strategic discussions with internal and external thought leaders
- Become a proficient assistant CRS and effective cross-functional study team contributor throughout the clinical study process by learning to develop a protocol concept sheet, clinical protocols, informed consent documents, clinical databases, patient narratives, clinical study reports, Investigator Brochures (IB), Investigational New Drug (IND) safety updates, case report forms (CRFs), and other regulatory submission documents
- Partner with the Clinical Operations team to ensure scientific alignment with operational objectives while conducting the study
- Lead the study team in comprehensive clinical data review and analysis in conjunction with the CRP
- Interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory, Early Development and Clinical Pharmacology, Medical Writing, Marketing, and Project Leadership
- Learn the role of the translational development laboratory components of a clinical trial through rotational activities
Students will perform independent work with a dedicated scientific/medical mentor and be involved in the development and conduct of a clinical trial collaborating with our worldwide teams (i.e. translational medicine, clinical operations, regulatory affairs, health outcomes research, etc) throughout the stages of the drug development process.
Responsibilities will include, but are not limited to, the following:
1. Reviews literature and assists with preparation of key documents e.g. protocols, protocol amendments, Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
2. Assist with the writing of Clinical Protocol and Informed Consent
3. Assist with the organization and execution of study committees (i.e. Data Monitoring Committee, Scientific Steering Committee, etc)
4. Contributes as a member of the Clinical Study Team
5. Assist with organization of internal and external clinical meetings. Prepare and review presentations for meetings.
6. Assist the Clinical Research Scientist and Clinical Research Physician to interface with the project team members including Clinical Operations, Data Management, Biostatistics, Drug Safety, Regulatory, and Project Management.
7. Assist with preparation and organization of key documents e.g. Protocols, Protocol Amendments, Clinical Study Reports (and appendices), Regulatory documents, internal or external presentations, etc.
8. Assists with organization and review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
9. Participates and assists in the preparation of Clinical Study Reports
10. Leads at least one Journal Review Session with Clinical Research Personnel
11. Attend required trainings on GCP/ICH, company policies as well as other relevant trainings
12. Other Assignments as determined by Manager and Mentor
- BS in Biology, Chemistry, or related pre-medical degree track.
- Candidates must be accepted to or intend to apply to Medical School
- Experience & knowledge of the drug development process, preferred
- Excellent verbal, written and communication skills
- Scientific & clinical research knowledge
- Ability to analyze data
- Ability to recognize potential problems and develop sound solutions
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Req ID: 17000064
Primary Location: United States-New Jersey-Summit
Job: Clinical Development
Organization: Celgene Corporation
Schedule: Limited Term
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Job Posting: 2017-01-13 00:00:00.0