Contract Clinical Research Associate opportunity. Client prefers candidates to be located in CA or CO but not required
erik.lombere@lombereindustries.com
Job description
Contract Clinical Research Associate opportunity. Client prefers candidates to be located in CA or CO but not required.
Medical device- *ISO 14155:2020 experience a plus
Position Summary/Role and Responsibilities:
Participates in clinical research programs by assisting with implementing study protocols, and conducting site qualification through close-out visits to support product commercialization. The selected professional will interface with clinical site staff, field monitors, Clinical Research Organizations (CRO), vendors, and cross functionally assist Quality and Regulatory Affairs with implementation of Good Clinical Practices.
Site management for 5+ sites
Provides site management by:
Assisting site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets protocol requirements, and ensures regulatory requirements are being fulfilled
Providing accurate and timely monitoring reports
Developing and ensuring strong site relationships through all phases of the trial
Serving as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols; including clinical case coverage
Travels to clinical sites to:
Ensure sites are in compliance (co-monitor until ready to monitor solo)
Conduct source document verification and enters queries in EDC as needed
Provide case coverage to support the site study coordinator on data collection and guidance on the randomization process
Ensures that documentation from investigators and investigational sites meets FDA/GCP requirements
Assists in site selection and activation activities
Creates binders for Site Initiation Visits
Supports implementing clinical research projects
Supports Trial Master File maintenance
Assists in tracking the effectiveness of recruitment and retention programs at sites
Tracks Investigational Product shipments, returns/disposal, and inventory
Manages screening logs and track reasons for screen failures
Assists with study protocol updates, case report forms, informed consent forms for sound and thorough data to support the device through the approval process
Organizes data in systematic manner to allow for efficient and accurate clinical reports
Performs adverse event initial and follow-up reporting activities and assists with DSMB and CEC AE review meetings
Interfaces with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities
Performs other clinical duties as requested
Qualifications and Education Requirements
Bachelor’s degree in health profession, life science and/or engineering field
2-5+ years experience in clinical affairs in the medical device, biotechnology or pharmaceutical industry
Knowledge/Skills:
Demonstrated strong writing skills in job responsibilities (e.g. monitoring reports, clinical sections of regulatory submissions, correspondence).
Effective oral communication and relationship building skills with internal/external representatives of all levels.
Computer literacy, proficiency in GSuite, EDC systems, MS Office, Excel, PowerPoint etc.
Excellent organizational skills and attention to detail.
Effective time management skills.
Ability to reason independently and recommend specific solutions in clinical settings.
Working Conditions:
Domestic travel is required, approximately 25 – 75% of time.
Ability to drive to local sites or travel long distances, occasionally for extended periods of time, and stand for 2+ hours during hospital procedures is necessary. For operating/procedure room access, criminal background checks, drug testing, vaccinations, etc. may be required by hospitals.
Job Types: Full-time, Contract