CE
Care New EnglandClinical Research Assistant III
Clinical Research Assistant III supporting pediatric research projects at Women & Infants Hospital. Collecting research data and overseeing study activities under the PI and/or project coordinator.
About the role
- Work collaboratively with the Global Development Lead (GDL) to establish, lead, coordinate, and execute the early oncology clinical development plan(s) for one or more novel biological or small molecule therapies
- Lead the preparation of clinical protocol and supports other critical documents
- Collaborate with Clinical Operations to ensure timely execution of First-in-Human (FIH) programs through proof-of-concept
- Participate in safety assessment and interpretation of clinical study results
- Regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead
- Support the transition early development clinical programs into late stage development
- Prepare presentations regarding strategy and/or data
- Assist with authoring clinical sections of regulatory documents
Requirements
- PhD/PharmD and 2+ years experience in a clinical scientist type role
- MA/MBA/MS and 5+ years clinical development experience including 2 years of experience in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone
- BA/BS/BSN and 7+ years of experience in clinical development including 2 years of experience in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone
- Experience in Oncology drug development especially in Early Development
- Familiarity with related disciplines (Biostatistics, Regulatory, Pre-Clinical Pharmacology, Pharmaceutical Sciences)
- Proven scientific writing skills and strong communication skills
- Demonstrated experience with GCP and (the ability to apply Pfizer policies and SOPs)
- Experience building consensus and driving change across all levels of the organization including senior management.
- Data listing review experience
- Experience working collaboratively in a fast-paced, team-based matrix environment as well as independently
- Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform
Benefits
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- paid vacation
- holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
DC
Duke CareersClinical Research Nurse Coordinator
Clinical Research Nurse Coordinator overseeing complex oncology clinical trials within Duke Cancer Institute. Managing study operations, collaborating with multidisciplinary teams, and maintaining regulatory compliance.
EC
Eli Lilly and CompanyClinical Research Scientist – Breast Cancer Franchise
Clinical Research Scientist developing innovative breast cancer therapies at Lilly. Collaborating with cross - functional partners in clinical trial design and execution.
SC
School of Information Technology at the University of CincinnatiClinical Research Professional II, Radiology
Clinical Research Professional II coordinating research activities at UC College of Medicine. Engaging in patient recruitment and maintaining compliance with research protocols.
Clinical Trial Manager overseeing planning, execution, and completion of clinical trials for ICON PLC. Collaborating with teams and managing site relationships to ensure compliance and successful delivery.
Senior Manager overseeing clinical trials in Late - stage Oncology at Pfizer. Providing scientific oversight and collaborating with clinical operations for successful trial execution.
Senior Manager in Late Stage Oncology ensuring quality and integrity of clinical trial processes at Pfizer. Collaborating with cross - functional teams to support drug development and regulatory submissions.
Principal Scientist at Merck managing clinical research activities in Immunology with focus on late - stage development. Overseeing clinical trials and collaborating with cross - functional teams.
SH
Syneos HealthSenior Clinical Trial Manager – Poland, hybrid model
Sr Clinical Trial Manager managing clinical trial oversight and ensuring compliance in Poland. Collaborating across teams to meet project milestones and patient safety standards with a hybrid work model.
GE
Senior Clinical Trial Manager at Genmab managing clinical trials and ensuring compliance with regulatory standards. Developing operational plans and coordinating with stakeholders for successful trial execution.