Project Manager

(ID: 2024-5259)

Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Benefits

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off (Including Holidays)
• Employee Referral Bonus
• 401K Match
• Tuition reimbursement and professional development opportunities
• Flexible Spending Accounts:
• Healthcare (FSA)
• Parking Reimbursement Account (PRK)
• Dependent Care Assistant Program (DCAP)
• Transportation Reimbursement Account (TRN)
  

Overview

Axle is seeking a highly ambitious, adaptable, structured, and detail-orientedProject Manager to join our vibrant team at the National Institutes of Health (NIH), Vaccine Research Center (VRC), Clinical Trials Program (CTP).

Technical Requirements

• Provide support in quality control review & clinical operations outreach to ensure compliancy within protocol/research standards specific to clinical trial development, recruitment /outreach, research data collection, and general clinical operations with use of the CTP Quality Management System (QMS); actively contribute to the accurate retention of complex clinical data/records, by acting as Quality Control and Clinic Outreach Liaison maintaining institutional and organizational Standard Operating Procedures (SOPs) and Federal regulations as required.
• Assure adherence to International Commission on Harmonization (ICH), Good Clinical Practice (GCP), and Code of Federal Regulations (CFR).
• Ensure clinical notes adhere to protocol requirements, accurate input of clinical data and records information, aligning database cross-communications to secure data integrity.
• Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review).
• Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
• Audit research records, source documentation and practices to monitor compliance with applicable regulations. Identify areas of potential risk through audit processes, as well as assist with presentation of audit findings and design and monitoring of necessary corrective action.
• Identify training opportunities based on audits, design and present such education to prevent repeated compliance risks.
• Work closely with Safety office team and Research Nurses/Study Coordinators to oversee the data management process.
• Perform Quality Control (QC) checks on all trials as needed.
• Identify potential problems or inconsistencies in documentation and execute data cleaning with precision in accordance with GCP mandates.
• Assist in providing monitoring support for all facets of clinical trials and research.
• Perform internal QC monitoring visits to assure the research data with accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.
• Assist in the overall recruitment and pre-screening effort of the team in accordance with each protocol utilizing VRC’s screening process criteria, in person or by telephone.
• Collect initial pre-screening health and demographic information by interviewing subjects to determine protocol eligibility
• Enter information and communications in database to secure data integrity.
• Assist with and participate in community engagement (in a variety of settings including college campuses, community events, and community based organizations) and study recruitment plans/strategies, to include marketing, community outreach, health education, etc. for all VRC clinical research studies in order to increase enrollment and name recognition.
• Assist in the development of recruitment materials such as data sheets, brochures, pre-screening documents, advertisement and other materials as appropriate for each engagement.
• Assist CTP team members with the day-to-day clinical administrative ops tasks, such as copying, filing and clinical data entry; maintain tools and supplies to ensure proper recruitment for research studies.
• Schedule participant screening visits in the VRC scheduling database.
• Respond and follow up to initial inquires through email and calls.
  
  

Specific Qualifications

• Bachelor’s degree in a related field.
• Minimum of two (2) years of experience in clinical research.
• Strong interpersonal and communications skills, both verbally and written.
• Strong organizational skills.
• Goal and detailed oriented.
• Ability to maintain a professional and positive attitude.
• Ability to work effectively in teams and independently.
• Proficient in MS Office Suite.
• Ability to simultaneously manage multiple projects.
  
  

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact:

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

#J-18808-Ljbffr