The Clinical Research Coordinator (CRC) is responsible for overseeing and coordinating all aspects of clinical trials, ensuring that studies are conducted in compliance with regulatory requirements, sponsor expectations, and Good Clinical Practice (GCP) guidelines. The CRC will act as the primary liaison between the clinical research team, patients, and external stakeholders, ensuring the efficient and timely execution of clinical research projects.

Responsibilities: Study Coordination: Coordinate and manage all aspects of clinical trials, including patient recruitment, screening, and enrollment. Schedule and oversee patient visits, ensuring timely collection of data and samples in accordance with the study protocol. Oversee site initiation, monitoring, closeout activities, and equipment calibration to ensure compliance with study protocols and regulations. Maintain study documentation, including case report forms, consent forms, and other essential study records. Review monitoring follow-up letters to ensure timely completion and resolution of identified issues. Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs). Manage the receipt, shipment, and storage of study drug and trial samples. Ensure proper handling and storage of study materials, medications, and biological samples. Generate invoices for study sponsors as applicable or assigned. Patient Interaction: Serve as the main point of contact for participants, answering questions and providing information regarding study protocols, treatment options, and expected outcomes. Ensure patients understand the study’s risks, benefits, and requirements by assisting in the informed consent process. Monitor and document patient progress throughout the study, ensuring that their safety and well-being are maintained. Data Management: Enter, maintain, and monitor study data in the clinical trial management system (CTMS) and other relevant databases. Perform quality control checks to ensure the accuracy and completeness of data. Collaborate with trial site staff, sponsor or CRO to resolve any discrepancies or issues with study data. Regulatory Compliance: Stay current with federal and global regulations, including ICH-GCP and FDA guidelines, and ensure the study's adherence to applicable regulatory requirements, as well as sponsor-specific requirements. Assist with the preparation and submission of study protocols, amendments, and regulatory documents to the Institutional Review Board (IRB). Prepare site materials, including training materials, regulatory binders, manuals, and support documentation, ensuring alignment with regulatory guidelines and ethical standards. Conduct training for study staff on regulatory requirements and ensure compliance with study protocols. Maintain regulatory binders and drug accountability documents for each study. Archive all documentation at the end of the study per Sponsor and FDA-required timelines. Study Team Collaboration: Work closely with the Principal Investigator, Clinical Research Manager, and other research staff to ensure the study’s success. Communicate with sponsor representatives, providing regular updates on study progress and patient enrollment. Assist with study recruitment strategies and participate in outreach activities.

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Associate Director, Analytical Development & QC

About the Position

We are seeking a highly motivated, self-driven and detail-oriented Associate Director of Analytical Development and Quality Control to join our CMC team.

This role will provide broad exposure across Formation Bio's portfolio, requiring the ability to flex between small molecule and biologics programs at different phases of development in an outsourced development model, requiring strong technical skillset, vendor management, and the ability to balance scientific rigor with program timelines.

Responsibilities

• In close collaboration with CDMOs and contract testing laboratories, lead development, optimisation and validation of phase-appropriate analytical methods for small molecule and biologics drug substances and drug products.
• Manage testing (in-process, release, stability) at CDMOs and contract testing laboratories.
• Provide technical oversight for method transfers, comparability assessments, and laboratory readiness.
• Lead selection, qualification, and ongoing performance management of external analytical vendors.
• Oversee and manage Formation Bio's stability studies across all programs, including review and approval of stability protocols and review and trending of stability data to support shelf-life and retest dating. Track and publish stability program metrics. Act as the primary contact for stability-related inquiries.
• Oversee and manage Formation Bio's critical reagents and reference standards inventory and testing.
• Lead investigations of release and stability OOS and OOT results, deviations, CAPAs and change controls.
• Author and review analytical sections of CMC documents, including protocols, reports, and regulatory submissions.
• Author and review of SOPs and work instructions.
• Closely collaborate with CMC, QA, and Regulatory teams.

About You

• Analytical Chemistry, Biochemistry, Molecular Biology, or a related discipline Master's degree with 5+ years or Bachelor's Degree with 8+ years of relevant small molecule and biologics analytical development and QC experience.
• Proven ability to operate effectively in a fast-paced, virtual, and outsourced development environment.
• Highly organised with a track record of managing multiple priorities across programs in an outsourced development model.
• Strong scientific judgement with the ability to independently assess data quality, identify risks, and recommend mitigation strategies.
• Ability to communicate complex analytical concepts clearly to both technical and non-technical stakeholders.
• Collaborative mindset with a strong sense of ownership and accountability.
• Extensive hands-on experience developing, optimising, and validating analytical methods for release and stability testing of small molecules and biologics.
• Hands-on experience with analytical methods pertinent to bilogics (qPCR, IEF, UHPLC, MS, CE, SDS-PAGE, ELISA, peptide mapping, glycan analysis, etc.) and small molecules (UHPLC, IC, GC, IR, UV, KF, PSD, dissolution, etc.).
• Experience with authoring and reviewing technical documents such as test methods, method development reports, validation protocols, validation reports, specification justification reports, retest and shelf-life memos, and SOPs.
• Experience with designing stability studies and performing stability data trending according to applicable guidances.
• Strong working knowledge of Smartsheet and JMP.
• Thorough understanding of ICH, FDA, EMA guidances and GMP requirements governing process development, manufacturing, and stability.
• Ability to travel domestically and internationally up to 25% of the time.

Total Compensation Range

$177,000 - $235,000

Where We Hire

Formation Bio is prioritising hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.

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