Clinical Trial Assistant
Intralytix is seeking a Clinical Trial Assistant to work (full-time, in-office) at our company headquarters in Columbia, Maryland. The successful applicant will provide technical and administrative support for clinical operations during all clinical trial stages and administrative in-house-activities, reporting to the Clinical Project Manager and/or the Director of Clinical Development, to meet company goals and manage our Sponsored clinical trials and associated activities. The CTA will have a primary role in TMF generation, management and reconciliation for multiple clinical trials. The CTA also will support all aspects of clinical operations by administering, maintaining and coordinating logistical aspects of clinical trial operations by collecting, producing and reviewing documentation, and maintaining electronic data and filing systems in compliance with study protocols, ICH/GCP, SOP and regulatory requirements.
Duties & Responsibilities:
Works with the Clinical Project Manager and/or Director of Clinical Development, and cross-functional project teams and Sites by assisting with tasks, including:
- Coordinating internal and external project team meetings, creating agendas and records meeting minutes, including the tracking of action items and decisions.
- Overall management and quality maintenance of essential clinical trial documents and other designated content, including generation, maintenance and reconciliation of eTMFs.
- Oversight of and assistance with eTMF completion, including collecting, appropriate content filing and maintenance, coordination of cross-functional documents, including third party and vendor content.
- Management and organization of the clinical operations and eTMF content within the shared electronic systems.
- Working with internal cross-functional teams to facilitate filing of appropriate eTMF content.
- Verifying receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, regulatory, and other non-clinical documents, as assigned.
- Ensuring all study information and documents are maintained and in compliance with study protocols, ICH/GCP, SOP and regulatory requirements.
- Collects study related documentation from clinical sites/providers, checks and performs quality control.
- Collaborates internally and externally with cross-functional teams, sites and vendors regarding study related activities (e.g., feasibility assessments, consultancy and NDAs).
Required Skills & Technical Expertise:
- Previous experience with Phase 1 and 2 trials essential.
- Knowledge of GCP, FDA and ICH regulations/guidelines for IND clinical trials and industry best practices.
- Understanding of core technical, scientific and medical terminology.
- Familiarity with eTMFs, eBinders, EDCs and/or other global electronic systems.
- Experience with preparing and filing regulatory documents.
- Experience supporting federal government contracts or grants is a plus.
Education & Previous Eexperience:
- Applicable clinical or TMF management certifications are preferred.
- B.S. in a Life Sciences or related discipline and 2+ years of relevant clinical experience in biotech/pharma – OR –
- M.S. in a Life Sciences or related discipline and 1+ years of relevant clinical experience in biotech/pharma.
- Experience within the life sciences industry, preferably biologics, biotechnology or pharmaceuticals, however medical devices is acceptable as well, performing within a clinical research role with prior TMF experience.
The salary will be commensurate with experience and qualifications. The benefits package includes health insurance, company paid life insurance and long-term disability insurance, and 401(K) with matching company contribution.
Please send a cover letter with a summary of experience, curriculum vitae, and the names and contact information of at least two references to:
Dr. Jennifer Schwartz
8681 Robert Fulton Dr.
Columbia, MD 21046.
Applications also can be e-mailed to firstname.lastname@example.org. No phone calls please.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. At the present time, Intralytix, Inc. is unable to support visa applications; therefore, all applicants must be already eligible for employment in the United States. Intralytix, Inc. is an equal opportunity employer.