ABOUT NOVEOME BIOTHERAPEUTICS, INC.
Noveome Biotherapeutics, Inc. is a clinical stage biopharmaceutical company with an innovative platform technology that represents a paradigm shift in the development of novel therapeutics. Unlike most drugs that are single molecules/single targets, Noveome’s product is a complex mixture of biomolecules that is believed to have the ability to address a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.
This Clinical Trial Associate II (CTA II) acts as the in-house support to the Clinical Operations team from protocol concept through trial completion. The position will focus on clinical study planning, start-up, and development including managing contracts, trial documents, and site communication. This position is responsible for assisting the Clinical Operations team by independently executing one or more elements in clinical trial management under the direction of the Clinical Trial manager (CTM) and VP of Clinical Operations. The CTA II will also manage the clinical study records from set-up to final archival, ensuring compliance with a focus on inspection readiness by maintaining the clinical Trial Master File (TMF). The position will support the company’s programs spanning from Phase I-III clinical trials. The position executes clinical projects according to Good Clinical Practice (GCP), International Conference of Harmonization (ICH) and Code of Federal Regulations (CFR) Guidelines as well as company procedures.
WHAT YOU WILL DO FOR NOVEOME
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Supports the CTM with CRO management
• Supports the CTM in review, collection, and tracking of clinical trial documents and site information • Monitors study progress and provides study status updates for assigned studies (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.). • Responsible for regular updates and supports the CTM in leading cross-functional team meetings. • Adheres to study timelines and manages study issues to support milestone achievement • Supports site selection activities, including the development of feasibility questionnaires • Assists in the development of the structure of the TMF and filing systems. Responsible for management of the Trial Master File (TMF), including filing of all study related documents.
• Supports vendor selection and possible oversight of assigned vendor activities. • Assists CTM in tracking contracts, invoices, and payments with CROs, consultants, vendors, and investigators, as appropriate.
• Assists with the development of newsletters, site communications, i.e. disseminating study information.
• Supports the development and implementation of standard operating procedures and common work practices within the team. • Assists the Clinical Trial Manager(s) with preparation, handling and distribution of clinical trial supplies and maintenance of tracking information. • Develop appropriate clinical tools and trackers to assist with study oversight.
Please note, as a company rooted in innovation our positions are consistently evolving and we champion the development of all roles. This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.
• Experience with EDC systems
• Basic knowledge of clinical research regulatory requirements; GCP and ICH guidelines
• Medical terminology
• Microsoft Office Word, Excel, and PowerPoint
• Study Coordinator and/or CRA experience
• eTMF experience
• Data management skills
• Drug development knowledge
ATTRIBUTES OF SUCCESS
Organization Prioritization Collaborative Ethical Interactive Communication
Results oriented Organization Persuasive Accountability Adaptability
PHYSICAL DEMANDS/WORK ENVIRONMENT
Subject to extended periods of sitting and/or standing, vision to monitor and typing. Work is generally performed in a temperature controlled office environment. Travel is required, up to 10% of the work week, mostly domestic. Work is performed in a mixture of team and independent environments.
This is a salaried non-exempt full time position with a regular schedule of Monday through Friday work hours. Extended hours may be needed on occasion to complete company objectives.
WHAT NOVEOME WILL DO FOR YOU
Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment. Eligible employees will appreciate the comprehensive benefits package and wellness perks.
REPORTS TO VP of Clinical Operations
MANAGES OTHERS NO
EDUCATION REQUIREMENTS BACHELOR’S DEGREE IN A LIFE SCIENCE OR HEALTHCARE DISCIPLINE
RELATED DEGREE PROGRAMS BIOLOGY, BIOCHEMISTRY, NURSING, PUBLIC HEALTH OR RELATED AREA
YEARS EXPERIENCE REQUIREMENTS 2+ YEARS OF ON-GOING CLINICAL TRIAL EXP IN THERAPEUTIC AREAS
BENEFICIAL CERTIFICATIONS CERTIFIED CLINICAL RESEARCH ASSOCIATE (CCRA),
CERTIFIED CLINICAL RESEARCH COORDINATOR (CCRC)
A combination of experience and/or education will be taken into consideration.
Noveome is an Equal Opportunity Employer.