General Medicine - FSP CRA 1
About The Position
Join a global team at the forefront of innovation as an FSP Clinical Research Associate (Level I). This role involves performing and coordinating all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure adherence to procedures and guidelines from various sponsors and monitoring environments (FSO, FSP, Government, etc.). As a site processes specialist, you will guarantee that trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs, ensuring subjects' rights, well-being, and data reliability. You will also ensure audit readiness and foster collaborative relationships with investigational sites. Detailed tasks and responsibilities are outlined in the task matrix.
Requirements
- Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a study coordinator, CTC, RN, MD or similar clinical role is required).
- Valid driver's license where applicable.
- Candidates must live within 60 miles of the nearest major airport.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, including a drug screening.
- Proven clinical monitoring skills.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents.
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
- Ability to manage Risk Based Monitoring concepts and processes.
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
- Good organizational and time management skills.
- Effective interpersonal skills.
- Attention to detail.
- Ability to remain flexible and adaptable in a wide range of scenarios.
- Ability to work in a team or independently as required.
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
- Good English language and grammar skills.
- Good presentation skills.
Responsibilities
- Perform and coordinate all aspects of the clinical monitoring and site management process.
- Conduct remote or on-site visits to assess protocol and regulatory compliance.
- Manage required documentation.
- Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.).
- Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
- Guarantee subjects' rights, well-being, and data reliability.
- Ensure audit readiness.
- Develop collaborative relationships with investigational sites.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
