Clinical Research Associate II (Cell Therapy)

Clinical Research Associate II (Cell Therapy)

Greater Toronto Area / Hybrid

Our 3 Core Values

• Intelligence

• Integrity

• Initiative

Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting!

What You'll Do

The Clinical Research Associate (CRA) II will be the primary liaison between the Investigator sites and Immix, responsible for overall site conduct and establishing important relationships with key site personnel. The CRA will perform key job functions in accordance with ICH Good Clinical Practice (ICH GCP), FDA regulations, Immix SOPs and work practices while supporting the organizational mission to advance the development of promising oncology therapies and technologies to benefit patients. CRAs are expected to work in a hands-on, highly visible and autonomous role. CRAs must have the ability to be flexible and represent Immix in a positive and professional manner while collaborating across all levels with the clinical teams and Sponsors/vendors.

Responsibilities:

• Perform site selection, initiation, monitoring, and close-out visits of investigational sites for the Nexcella portfolio of clinical trials.

• Manage the progress of assigned sites by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, data collection, and data query generation and resolution.

• Conduct monitoring activities, including, but not limited to the following:

o Ensuring PI oversight of all trial activities

o Source data review and verification with EDC fields

o Essential documentation review and reconciliation

o Investigational Product (IP) management and accountability

o Lab/kit supply management

• Develop collaborative relationships with investigative sites and personnel.

• Maintain communication with sites through frequent contact to ensure site compliance, adequate enrollment, and understanding of study requirements.

• Write and submit complete and accurate visit letters and reports of investigational site findings and update applicable CTMS.

• Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.

• Participate in audit preparations and follow-up, as needed.

• Review and address protocol deviations, data quality issues, and identify process improvements for assigned sites.

• Be a collaborative member of the study team: provide insight, updates, and strategies to improve processes.

• Ability to think critically while prioritizing tasks in an efficient manner to meet study deliverables.

• Contribute to CRF development and perform User Access Testing, as requested.

• Assist with other duties as assigned.

Qualifications:

• Bachelor’s degree in life science/biomedical/medical science with a proficient knowledge of the clinical/scientific terminology and methods common to the oncology therapeutic setting.

• 2+ years clinical research experience is required.

• 2+ years experience at a CRO or Sponsor required.

• Independent field monitoring experience of oncology clinical trials is required.

• Early phase oncology experience is preferred.

• Proficient knowledge and practical utilization of ICH- GCP and applicable regulatory requirements.

• Strong communication (written and verbal) and interpersonal skills.

• Demonstrate effective presentation skills by clearly explaining complex concepts to a broad range of audiences.

• Ability to independently prioritize tasks with excellent time management skills.

• Highly proficient in computer applications including Microsoft suite of applications, EDC and CTMS applications.

• Fluent in English (written and verbal)

About Immix

Immix Biopharma, Inc. is a global leader in AL amyloidosis. AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a proprietary CD3ζ, CD8 hinge and binder “digital filter” designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL amyloidosis NEXICART-2 (NCT06097832), with a potentially registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.