Clinical Research Associate Jobs

Our Culture: Why work with us?

We value the diversity of backgrounds, ideas, opinions, and life experiences that our team members bring to Candel. We are incredibly proud that as we have grown, our vibrant culture has remained steadfast. Our Leaders are accessible, authentic, and invest in their employees.

Our Science:

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors with a robust pipeline. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life. Please visit www.Candeltx.com for additional information.

What is in it for you:

If you have 1-3 years clinical research experience, a dynamic personality, and solid organizational skills (with great attention to detail) then this role might be a great fit for you! In this role you will work as a liaison between the clinical sites and Candel Therapeutics. This includes overall site management with site initiation, monitoring, and close out visits, source data verification, query resolution, maintenance of site essential documents, IRB submissions, budget invoicing and reporting statuses to relevant clinical teams. This role requires initiating and managing the communications for consistent site management, accurate data collection and maintenance, regulatory submissions, and scheduling meetings with sites and internal teams. This role may also include working on multiple protocols with potential to be across different oncology indications using a variety of clinical trial databases. Work is performed in a collaborative team environment requiring self-initiative and drive. Our focus is on the patient and how what we do contributes to delivering hope. A positive can-do attitude is a must.

A day in the life of this role:

• Participate in maintaining accuracy within clinical management systems and internal reports and trackers.
• Participate in the development, maintenance, and distribution of Clinical Standard Operating Procedures (SOPs), Case Report Forms (CRFs) and other supporting documents.
• Provide assistance in auditing central files and collecting, tracking, and summarizing patient information to relevant team members.
• Conduct site initiation, monitoring, and closure visits and prepare and submit written reports in a timely, concise, and objective manner.
• Assist in the collection and completion of essential study site regulatory documents and maintain ongoing submissions/updates of site information in relevant databases and IRB interfaces supporting an accurate TMF.
• Serve as a primary point of communication between Candel and clinical sites including dissemination of information to the project team, investigators, study coordinators, and physicians.
• Participate in risk-based monitoring and source data verification for assigned sites to monitor quality of data is across multiple protocols
• Work with study sites to ensure compliance with the protocol and overall clinical objectives inclusive of enrollment efforts if applicable.
• Participate in protocol presentations and maintain initial and ongoing training of site personnel.
• Ensure quality of data submitted from assigned study sites and assure timely submission of data, including appropriate reporting, follow-up for all safety events, and data query resolution.

What we will need from you:

• Discretion in handling confidential information.
• Able to manage multiple projects independently and use varying databases and management systems.
• Knowledge of GCP and FDA regulations related to clinical trial conduct and familiarity with industry best practices.
• Requires a bachelor’s degree, preferably in a health-related discipline.
• Minimum 1-3 years relevant clinical research experience.
• Excellent verbal and written communication skills, good organizational and interpersonal skills, and a team drive.
• Experience in oncology desirable but not required.
• Positive attitude with a real desire to make a difference for the patients.
• Knowledge of project management tools and practices, and proficiency in using normal office software; Microsoft Word, Excel and PowerPoint.

What will make you a good fit with this role:

• Comradery: You build genuine relationships. You trust your co-workers. You genuinely enjoy working together and understand we are all more successful when we work as a team
• Perseverance: You have a “can do” attitude and do not mind rolling up your sleeves and pitching in. You always go above and beyond
• Daring: You are comfortable taking risks and (appropriately) pushing boundaries. You work hard and challenge the status quo
• Intellectual curiosity: You enjoy thinking deeply. You have a thirst for learning. You relish sharing knowledge and know how to have fun doing so!

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