Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early- to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Please visit www.candeltx.com for additional information.
If you have 1-3 years clinical research experience, a dynamic personality, and solid organizational skills (with great attention to details) 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, data source 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.
- 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 protocol presentations and maintain initial and ongoing training of site personnel.
- 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.
- 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.
- Work with study sites to ensure compliance with the protocol and overall clinical objectives inclusive of enrollment efforts if applicable.
- Participate in maintaining accuracy within clinical management systems and internal reports and trackers.
- Provide assistance in auditing central files and collecting, tracking, and summarizing patient information to relevant team members.
- Participate in the development, maintenance, and distribution of Clinical Standard Operating Procedures (SOPs), Case Report Forms (CRFs) and other supporting documents.
- 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.
- Knowledge of GCP and FDA regulations related to clinical trial conduct and familiarity with industry best practices.
- Able to manage multiple projects independently and use varying databases and management systems.
- Discretion in handling confidential information.
- Knowledge of project management tools and practices, and proficiency in using normal office software; Microsoft Word, Excel and PowerPoint.
- Positive attitude with a real desire to make a difference for the patients.
- Experience in oncology desirable but not required.
Interested candidates please submit your resume to firstname.lastname@example.org