Senior Clinical Trial Associate

Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies.  The company is located in Gaithersburg, Maryland and the SF Bay Area.  We have assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and clinical development.  Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

Primary Objective

• Provide support to the clinical trial team with tasks involved in clinical development operations at Arcellx.

Main Accountabilities:

• Collaborate with the clinical trial team to plan and implement action to address issues.
• Work with contract research organizations, vendors and project support stakeholders to ensure clinical trial deliverables are met.
• Track study progress including patient enrollment and patient status
• Oversight of Regulatory documents for site initiation.
• Support the Study Team by creating and distributing study team materials, tools and documents where needed.
• Assist with supply ordering and tracking as needed.
• Provide study metrics and reports as requested.
• Process and track payments to vendors and study sites as appropriate.
• Oversee TMF Quality Review for study team and complete TMF QC for department on a as required by study.
• Assist the clinical / data management team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Participate in review of case report forms and eCRF completion guidelines. Provide user acceptable testing as needed.
• Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors.
• May assist study team in review of monitoring visit reports and unresolved action items.
• Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
• Perform review of vendor invoices including tracking and generation of monthly/quarterly accruals for finance.
• Assist with generating the CSR appendices or other clinical documents and presentations as requested.
• Participate in Standard Operating Procedure development
• Maintain primary database for clinical sites, study team and vendors
• Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives.

Preferred Qualifications:

• Completed BA/BS in directly-relevant discipline or equivalent experience required.
• 4+ years experience as CTA (or comparable operating experience) in pharmaceutical, CRO, or healthcare environment(s) required.
• Basic knowledge of ICH GCP guidelines and other regulatory requirements.
• Proficient in using Microsoft programs including Word, Excel, Powerpoint, OneNote, Teams and Outlook
• Able to prioritize and managing competing priorities.
• Team-oriented and excellent communication skills.

Competencies:

• Commitment to ethical scientific investigations and rigorous experimental methods.
• Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
  Sense of urgency in performance of duties.
• Interpersonal skills that promote a collaborative and productive lab environment.
• Effective and efficient written and oral communication skills.

Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.