Clinical Trial Associate
2 weeks ago
The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
The Alliance for Clinical Trials in Oncology Foundation is looking for a Clinical Trial Associate who is excited to support the Pharmaceutical Collaborations Team and cross-departmental collaboration needs for Alliance NCTN trials. The CTA’s involvement includes (but is not limited to) supporting trial development needs, CRO vendor oversight, site management, project management, and program management. We are an organization of passionate, team-oriented professionals driven to change the face of cancer.
Benefits of working at the Alliance for Clinical Trials in Oncology Foundation:
● 8 weeks of paid time off (including PTO, sick, and holidays) during year one
● Medical, Dental & Vision plans with 100% employer-paid option for employees
● Tuition reimbursement stipends
● Continuing Education
● 3% employer match for retirement investments
● Annual Employee Performance Bonus Program
● Annual Cost of Living Adjustment
● 50% commuter reimbursement
● Healthy Work/Life balance and flexibility
Requirements
ROLE & RESPONSIBILITIES
- Assist in preparing, organizing, and maintaining documents such as for the program or for a specific trial
- Ensuring appropriate filing/storing of study-documents, in accordance with FDA Code of Federal Regulation (CFR), International Conference of Harmonization (ICH), Good Clinical Practice guidelines and Alliance policies and procedures
- Maintain oversight of signature routing, in accordance with CFR/ICH/GCP guidelines, for finalizing study document
- Tracking study documents/materials for oversight of engagement with pharmaceutical partners
- Identifying and tracking deviations from study plans, in accordance with CFR, ICH, and GCP guidelines
- Support site engagement by executing established plans, such as for site staff training
- Support accrual enhancement by providing oversight and implementing established study-specific plans
- Track significant trial events, such as for issues that arise and the associated resolution
- Assist with the creation of start-up plans and templates
- Accurately enter and manage activity within project management systems/plans
- Facilitate communication with site monitoring CROs
- Engage in site management and trial management by overseeing study-specific mailboxes
- Work closely with Project Coordinator, Project Manager, Clinical Study Manager, Director of Industry Collaborations & Trial Management
- Oversee adherence to study-specific monitoring requirements such as monitoring visit timelines or monitoring reports occurring within the required time frame
- Support monitoring needs by supporting oversight of the quantity of data review needs
- Cross-collaboration with internal departments/teams such as Budgets, Contracts, Protocol, Quality, Statistics and Data management, Executive/Senior Leadership, etc
- Other related duties as assigned to meet program and organizational objectives
QUALIFICATIONS & EDUCATION REQUIREMENTS
- A minimum of BA/BS degree is required
- Degree in a health or life science major preferred
- 1-2 years of relevant experience in biotech, pharma, and/or CRO or 2-4 years of relevant project management experience required
- Working knowledge of ICH/GCP/CFR guidelines required
- Demonstrated project management skills preferred
- Proficiency in Microsoft Office Suite required
- Strong organizational skills and ability to prioritize workload to meet tight deadlines in a dynamic work environment
- Strong interpersonal, written, and verbal communication skills required
- Ability to effectively work within a team and independently required
- Flexibility and adaptability to workplace environment undergoing change management to support scaling of business required
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