Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
Assist in implementing clinical research projects
Review case report forms and informed consent forms against the study protocol and other governing documents to allow for accurate and thorough data collection to support the product through the regulatory approval process
Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements
Organize data in systematic manner to allow for efficient and accurate clinical reports.
Perform joint site visits with other CRAs to ensure regulatory and study requirements are being fulfilled

Requirements

Bachelor's degree in a scientific or health care discipline preferred and /or training; or equivalent combination of education and experience.
2+ years' recent experience in clinical role
Excellent verbal and written communication skills
Excellent organizational skills along with strong attention to detail
Ability to work both independently and collaboratively with cross-functional teams
Highly proficient with Microsoft Office Suite
Ability to travel approximately 35-40%

Benefits

Full medical coverage
Wellness programs
On-site gym
401(k) plan with employer match
Short-term and long-term disability coverage
Basic life insurance
Wellbeing benefits
Flexible or paid time off
Paid parental leave
Paid holidays

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchdata collectioncase report formsinformed consent formsregulatory approval processprotocol requirementsdata organizationdocumentation reviewGCPICH

Soft Skills

verbal communicationwritten communicationorganizational skillsattention to detailindependent workcollaborative workcross-functional teamwork