Clinical Research Associate Ii

Clinical Research Associate II (Cell Therapy)

Greater São Paulo 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 Nexcella, 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, Nexcella 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 Nexcella 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 Nexcella

Nexcella Inc., a wholly-owned Immix Biopharma subsidiary, is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.

Learn more at www.Nexcella.Com