Arcellx (http://www.arcellx.com/) 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.
- Provide support to the clinical trial team with tasks involved in clinical development operations at Arcellx.
- 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.
- 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.
- 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.
Submit cover letter and resume to: firstname.lastname@example.org
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.