Clinical Research Associate

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 1-2 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 (source verification), site closure, query resolution, maintenance of site essential documents, IRB submissions and reporting status to the clinical team. The role also requires managing the communications for consistent site enrollment and accurate patient form completion, regulatory submissions, data collection and scheduling meetings with sites. This role will 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 required.

Responsibilities:

  • 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 initial and ongoing training of site personnel, help generate initial and ongoing study excitement and enrollment targets, site initiation and monitoring visits, data query resolution and ongoing entry and updates of site information in databases and IRB interfaces.
  • Assist in the collection and maintenance of essential study site regulatory documents.
  • Participate in development and execution of patient recruitment efforts with each site.
  • Ensure quality of data submitted from assigned study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events.
  • Prepare and submit written reports in a timely, concise, and objective manner.
  • Work with study sites to ensure compliance with the protocol and overall clinical objectives.
  • Participates in the upkeep of 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 documents.

Requirements:

  • Requires a Bachelors’ degree, preferably in a health-related discipline.
  • Excellent verbal and written communication, organizational, and interpersonal skills with a team drive.
  • Minimum 1-2 years relevant clinical research experience.
  • Knowledge of GCP and FDA regulations related to clinical trial conduct and familiarity of industry best practices.
  • Able to manage multiple projects independently and use varying databases accordingly
  • Discretion in handling confidential information.
  • Knowledge of project management tools and practices, and proficient in using normal office software; Microsoft Word, Excel and PowerPoint.
  • Positive attitude with a real desire to hopefully make a difference for the patients
  • Experience in Urology or Oncology desirable but not required

Interested candidates please submit your resume to careers@candeltx.com