Clinical Trial Coordinator

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.

We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.

Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.

We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.

With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. 

Summary:

Reporting to AD/Dir Clinical Operations, the Clinical Trial Coordinator will support all administrative aspects of study management from start-up through closeout.   

• Responsible for taking and distributing meeting minutes for both internal and external meetings.
• Scheduling activities and setup of meetings, including compilation of materials and overseeing presentations
• Review study vendor meeting minutes and documents for accuracy.
• Filing and routing of agreements related to Clinical Operations.
• Preparing and tracking green light packets/ essential document packets for review as applicable based on training and experience.
• Updating trackers for metric reporting
• May be responsible for certain vendor management activities
• TMF and file maintenance
• Distributes, collects, and tracks large amounts of documentation accurately and within project timelines.
• Assists with preparation of reports and technical or scientific publications, as required.

• Bachelor’s Degree
• Experience in a CRO, Sponsor or clinical research administration function, including hands on experience relating to the essential documentation of a clinical trial strongly preferred.
• Excellent computer skills including knowledge of MSOffice.
• Good understanding of the policies and procedures related to Clinical Operations, Clinical Quality Compliance and ICH-GCP, particularly relating to essential documentation
• Excellent time and priority management
• Able to work efficiently under pressure
• Excellent organizational and problem-solving skills
• Thrives in a fast-paced and evolving environment
• Self-motivated, shows initiative, is proactive and able to work on his/her own as well as in a team
• Excellent communication skills - both verbal and written
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.

Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.