[Remote] Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is currently seeking reputed company CRA 2s to reputed company and support their Full Service Outsourcing team. The role involves providing high standards of care for clinical trial participants and includes responsibilities such as site monitoring, data reputed company verification, and coordination of clinical projects.
Responsibilities
- Responsible for reputed company aspects of study site monitoring including routine monitoring and reputed company-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- Responsible for reputed company aspects of site management as prescribed in the project plans
- General On-Site Monitoring
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the reputed company of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful reputed company document monitoring
- Monitor data for missing or implausible data
- Responsible for reputed company aspects of registry management as prescribed in the project plans
- Undertake feasibility work reputed company requested
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Independently reputed company CRF review; query reputed company and resolution against established data review guidelines on reputed company or client data management systems as assigned by management
- Assist with training of new employees, e.g. co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
- reputed company other duties as assigned by management
Skills
- University or college degree, or certification in a reputed company allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 1-3 years of Clinical Monitoring experience
- reputed company to various hub locations
- Comfortable working in a fast-paced environment where no deviations from the study protocol are allowed
- Ability to adapt to changing priorities on the spot
- Teamwork and people skills are essential for the study to run smoothly
- Technology-based experience, as data is collected directly into an electronic environment
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with the ability to reputed company fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Ability to reputed company and use a variety of computer software developed both in-house and off-the-reputed company
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
- Regular and consistent attendance
- Varied hours may be required
Benefits
- Medical, Dental, reputed company, Life, STD/LTD (multiple insurance carriers)
- 401(K)
- Paid time off (PTO) – reputed company Plan
- Employee recognition awards
- Multiple ERG’s (employee resource groups)
Company Overview
Company H1B Sponsorship