- 经验
- 2年以上
- 薪水
- USD 88,000 – USD 100,000 / year
- 职位空缺
- 1
- 发布
- 4小时前
- 工作模式
- 在办公室
- 学历
- Bachelor’s degree in a health-related discipline or equivalent
- 合格
- Applicants must be authorized to work in the United States; sponsorship is not offered. Resumes from staffing agencies will not be accepted.
- 恢复
- 需要申请
你的工作地点
职位描述
About Candel Therapeutics
Candel Therapeutics operates from Needham, MA, focusing on creating innovative cancer immunotherapies. This clinical-stage biopharma company specializes in developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor immune responses, utilizing genetically modified adenovirus and HSV platforms. With successful Phase 3 clinical results for their primary candidate, the company fosters a mission-driven culture of diversity, collaboration, and empowerment designed to innovate and impact patient care.
Role Overview
The Clinical Trial Associate (CTA) is instrumental in supporting clinical trial execution across Phase 2 and Phase 3 studies. The role covers multiple protocols and offers opportunities to gain exposure across various oncology indications and clinical trial database systems.
Key Responsibilities
- Execute and manage daily clinical trial operations in strict compliance with protocols, timelines, and regulatory standards.
- Engage in reviewing, adapting, and finalizing study templates, logs, plans, and manuals, as well as training staff continually.
- Assist in the collection and completion of critical study tasks, including data entry into various databases.
- Maintain the accuracy and timely submission of clinical data, including progress reports.
- Oversee imaging vendor relationships, invoice tracking, shipment, and sample recovery processes.
- Help plan and organize study meetings, compose updates, and distribute information regularly.
- Support Clinical Trial Manager by assisting with site management functions such as monitoring report evaluations and source document reviews.
- Maintain clinical study trackers supporting both individual studies and overall clinical operations.
- Conduct primary review of submitted clinical data, database entry, and source verification per SOPs.
- Participate in data verification and quality control processes to ensure data integrity.
- Ensure meticulous documentation and archiving of clinical data.
- Support budget-related tasks including invoice tracking and purchase order coordination.
Candidate Requirements
- Bachelor’s degree in a health-related field or comparable discipline.
- Minimum of 2 years' relevant experience within clinical research, pharmaceutical, or biotech settings, understanding clinical operations' regulatory environments.
- Strong verbal and written communication capabilities, organizational skills, team collaboration, and motivation.
- Working knowledge of Good Clinical Practice (GCP), FDA regulations on clinical trials, and contemporary industry standards.
- Capability to independently manage multiple projects and proficiency with diverse databases and management systems.
- Ability to handle confidential information with discretion.
- Familiarity with project management methodologies and competent use of MS Word, Excel, and PowerPoint.
- Authorization to work in the United States is mandatory; sponsorship is not available.
Additional Information
Applicants are advised that resumes submitted through staffing agencies will not be considered.
Compensation and Location
- Position location is hybrid at Needham, MA.
- Annual salary range: $88,000 to $100,000.