Medical Device Cra Jobs (NOW HIRING)

Description
We are looking for an experienced Senior Clinical Research Associate with a strong background in medical device studies and independent consulting. This remote consulting opportunity supports a growing Medical Technology client and is ideal for a CRA who enjoys working in a fast-paced environment while contributing to meaningful clinical research initiatives. Candidates should live within driving distance of the Greater New York City area and be comfortable with travel for on-site monitoring activities.
This consulting engagement is focused on experienced professionals who understand the full clinical trial lifecycle, site monitoring responsibilities, and the importance of regulatory compliance and data integrity. The position offers flexibility in a remote setting while remaining highly collaborative with study teams, investigators, and sponsors.
Responsibilities
• Sr. CRA (Remote / Home-Based with on-site travel required)
• Interfaces with the study team to ensure the timely initiation and completion of clinical trials
• Responsible for the identification, evaluation, and qualification of investigators and sites
• May prepare and submit essential document packages required for clinical site initiation
• Performs on-site monitoring activities for clinical trials and escalates site issues to Lead Clinical Research Associate (LCRA) and/or Clinical Trial Manager (CTM) as appropriate; documents activities in the monitoring reports and follow-up correspondence
• Reviews and manages data on site and remotely; resolves issues on a continuous basis to achieve timely database targets
• • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, and close-out visits of clinical sites, and maintenance of study files, with or without guidance
• Ensure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Identify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities.
• Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor the study database for missing or discrepant data compared to the source record at the clinical site
• Ensure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan)
• Maintain study blind and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision
• Attend investigators' meetings, project team meetings, and teleconferences, as needed
• Understands and applies knowledge regarding local, state, and country regulations (i.e., TGA, etc.) and ICH-GCP
• Maintain training on ICH-GCP, study protocol, and client procedures
• May track regulatory documents, may track recruitment, may evaluate study site quality and integrity, and may motivate assigned sites to meet client deadlines
Qualifications
• 4 years or more as a MEDICAL DEVICE CRA with site monitoring responsibility AND 2 years or more as a Contract CRA
AND
• The candidate possesses a 4-year university degree, ideally in a scientific field
• In lieu of a 4-year university degree, a candidate with a 3-year bachelor's program, such as a BSN, or early completion of a 4-year degree with a diploma will be considered.
• Must have working rights in the United States
• Must be located in: New York City or the Greater New York City area, within 1 hour of an airport
• The candidate must have availability to fulfill the assignment for the duration of the contract.
• Must possess exemplary verbal skills in the English language, with the ability to solve complex problems using medical terminology
• Must be proficient at tactfully managing intra-team communication, as well as interpersonal communication
• Must have the ability to set up with appropriate insurance and state requirements to receive work as a vendor.