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Clinical Research Associate Jobs
Company | Candel Therapeutics |
Address | Needham, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet Publishing |
Expires | 2023-09-07 |
Posted at | 8 months ago |
Our Culture: Why work with us?
- Provide assistance in auditing central files and collecting, tracking, and summarizing patient information to relevant team members.
- 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
- 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.
- Participate in maintaining accuracy within clinical management systems and internal reports and trackers.
- 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.
- Conduct site initiation, monitoring, and closure visits and 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 inclusive of enrollment efforts if applicable.
- Participate in the development, maintenance, and distribution of Clinical Standard Operating Procedures (SOPs), Case Report Forms (CRFs) and other supporting documents.
- Participate in protocol presentations and maintain initial and ongoing training of site personnel.
- Excellent verbal and written communication skills, good organizational and interpersonal skills, and a team drive.
- Requires a bachelor’s degree, preferably in a health-related discipline.
- Positive attitude with a real desire to make a difference for the patients.
- Experience in oncology desirable but not required.
- Able to manage multiple projects independently and use varying databases and management systems.
- Discretion in handling confidential information.
- Knowledge of GCP and FDA regulations related to clinical trial conduct and familiarity with industry best practices.
- Knowledge of project management tools and practices, and proficiency in using normal office software; Microsoft Word, Excel and PowerPoint.
- Minimum 1-3 years relevant clinical research experience.
- Daring: You are comfortable taking risks and (appropriately) pushing boundaries. You work hard and challenge the status quo
- Perseverance: You have a “can do” attitude and do not mind rolling up your sleeves and pitching in. You always go above and beyond
- 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
- 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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