Sr Clinical Research Associate

Sr Clinical Research Associate:

Arcellx, Inc. () is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.

Locations: Mid Atlantic / Northeast and Midwest

Purpose:

• Performs monitoring, site management and CRO oversight activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.
• Works closely with the Project manager (PM), Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.

Key Performance Objectives:

• Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
• Collaborate with the internal and CRO team and associated study vendors to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
• Perform study initiation activities by reviewing with the site personnel the protocol, regulatory requirements, study procedures, completion of eCRFs, monitoring activities, and study close-out activities.
• Assists with, the preparation and conduct of Investigator Meetings for assigned studies.
• Act as resource for study sites to assist in resolving any potential/found site audit findings to ensure compliance with Sponsor, CRO and site file audits.
• Assure site adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site or remote monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined within study specific plans or Arcellx SOPs.
• Performs site investigational product inventory accountability, including site documentation, and storage conditions of clinical trial materials as required by sponsor.
• Review the quality and integrity of the clinical data through (1) review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.
• May assist in the preparation of study related documents such as protocols, eCRFs, and study manuals as requested.
• Serve as - contact between Arcellx and investigator site; coordinates - correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
• -Report any site data integrity or quality concerns to appropriate Arcellx clinical project team/QA, discuss and request site audits.
• Ensure site study-related trainings and deliverables are completed per Arcellx and/or study timelines.
• May assume clinical lead tasks as assigned, acting as Clinical Lead for a project or assessor of peers for sign-off visit reports (as approved).
• Perform other duties, as requested.

Qualifications & Competencies:

• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and regulatory requirements.
• Six plus years of Immuno-oncology therapeutic area including CAR-T therapy and early phase research design.

• Knowledge of risk-based monitoring (RBM), key risk indictors (KRIs) and quality matrix.
• Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
• Ability to handle several priorities within multiple, complex trials.
• Ability to mentor other CRAs and co-monitor, as required.
• Ability to travel globally and domestically as needed.