AffyImmune Therapeutics (“Affy”), a clinical stage biotechnology company focused on developing technologies that expand the utility and improve the safety and efficacy of cell-based immunotherapy for cancer, is seeking a Clinical Research Associate to help advance the use of CAR T therapy for solid tumors. As part of the clinical team, you will build key relationships with site staff, ensure compliance with Affy’s protocol and applicable regulations, and help ensure successful delivery of Affy’s clinical trials.
As a CRA, you will join a small team at a dynamic startup. You will collaborate within and outside the company to help us advance both our technology and product development. With your persistence, attention to detail, and enthusiasm, you will leave an indelible mark on Affy. Affy will not accept resumes from recruiters for this role.
CLINICAL RESEARCH ASSOCIATE (SENIOR CRA, DOE)
Site Monitoring (80%)
- Conduct site selection, site initiation, interim monitoring, and closeout visits either via remote or in-person visits. Document visits via confirmation letter, report, and follow-up letter as applicable.
- Verify the process of obtaining informed consent has been adequately performed and documented at each clinical trial site, to ensure clinical trial patients’ rights, safety and well-being are protected.
- Ensure integrity of the data submitted on Case Report Forms (CRF) via the Electronic Data Capture (EDC) system with appropriate source data verification. Assist clinical trial sites with query resolution. Liaise with Associate Director, Data Management for data questions, queries and data quality concerns.
- Manage investigational product accountability
- Identify and report protocol deviations in accordance with Protocol and study plans
- Partner with clinical sites to adapt, drive, and track patient recruitment plans in line with project needs.
- Manage clinical sites study and enrollment expectations
- Administer protocol and related study trainings to clinical trial staff at assigned sites and establish regular communication with sites to manage ongoing project expectations and issues.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Maintain and help build strong relationships with clinical sites
- Evaluate the quality and integrity of site study practices as they relate to assigned protocols and applicable regulations. Escalate quality issues as appropriate.
- Collect and review site essential documents from clinical trial sites, from site start-up through site close-out. Work to correct deficient documents with clinical trial sites.
- Ensure copies or originals of site essential documents are available for filing in the eTMF and verify the investigator site file is maintained in accordance with relevant guidance and regulations.
- Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution. Support site start-up as required.
Operations Support (20%)
- Support CTM with site financial management according to executed clinical trial agreements.
- Assist in the development of study tools, trackers, site and patient-facing materials, as needed
- Ensure clinical sites have sufficient protocol required supply quantities and place orders as needed.
- Participate in functional and company-wide meetings to keep all team members apprised of progress.
- Perform other duties as assigned.
- Bachelor’s degree required. Degree in scientific or healthcare discipline preferred. 4+ years of monitoring experience (onsite and remote) required. Additional, relevant experience may be considered in lieu of degree.
- Subject matter expertise in clinical research regulatory requirements, namely GCP and ICH.
- Strong cell therapy, rare disease, and/or oncology experience required. Electronic Medical Record (EMR) system and electronic Investigator Site File (ISF) experience a plus. Prior CAR T experience a plus, but not required.
- Excellent written and verbal communication and data analysis skills.
- Meticulous attention to detail, including capacity to conduct thorough self-reviews.
- Ability to interact positively with scientific and non-technical peers.
- Highly organized, collaborative, and motivated in a fast-paced startup environment.
- Travel: 25-50%. Experience remote monitoring a must given increased shift to remote over in-person visits.
- Competency with Microsoft Office (PowerPoint, Excel, Word, OneDrive) and other research-oriented software.
This is a salaried, benefits-eligible position.