Current Openings

  • The Clinical Trial Associate (CTA) is a key role that supports directly senior Clinical Operations staff responsible for the planning, execution and management of in-house or outsourced clinical trials. The successful candidate will perform daily clinical trial execution activities associated with the conduct of investigational clinical studies. He/she must exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks. Strong organizational skills are required, as well as the ability to balance changing priorities.

    Responsibilities:

    • Key support role to senior Clinical Operations staff; ensures that delegated components of clinical trials are executed to expected and specified quality standards
    • Schedule and coordinate study meetings, materials and agendas; record and disseminate decisions and actions
    • Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
    • Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
    • Create and maintain the Trial Master File and electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
    • Participate in drafting and coordinate review of site documents e.g. ICF, advertising materials
    • Collect, review, file and/or track clinical trial associated documents and regulatory packages
    • Assist in developing study plans, including Lab Manual, Clinical Monitoring Plan, Study Plan, Study Vendor Oversight Plan, Pharmacy Manual, and other. Monitor compliance to plans.
    • Work directly with study sites including performing site training, review of site study packets and study files
    • Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities.
    • Support investigational product supply logistics.
    • Responsible for study laboratory sample management, including tracking and vendor management support
    • Coordinate and track clinical trial equipment and supplies.
    • Assist with site budget process.
    • Review and track vendor invoices against contracts and coordinate approval.
    • Act as central point of communication with study sites and vendor personnel.
    • Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs
    • Maintain and ensure all documentation is in a state of audit readiness.
    • Assist in the coordination of Investigator Meetings.

    Requirement/Qualifications:

    • Bachelor’s degree in life sciences or healthcare related field
    • At least 2+ year experience in clinical operations within sponsor company, CRO or investigational site strongly preferred. Ideal candidate will have experience with gene/cell therapy product
    • Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
    • Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations as required
    • Solid understanding of the responsibilities and needs of other functions in a clinical trial
    • Experience working closely with study sites, Key Opinion Leaders (KOLs) and external vendors
    • Experience with eTMF; ability to directly apply essential document knowledge to file documents
    • Proficient in MS Excel, Outlook, Word and PowerPoint. Knowledge of MS project preferred.
    • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
    • A team player that takes initiative and has proven ability to work independently and effectively handle multiple priorities in a fast-paced environment.
    • Excellent interpersonal/team skills, strong organizational skills
    • Proficient written and verbal communication skills.
    • Strong customer service
    • Strong attention to quality/detail
    • Ability to maintain confidentiality of proprietary information expected.
    • Position may require some travel.