Tribute Technology · 4 hours ago
Clinical Research Associate II
United States
Full-time
Remote
Entry, Mid Level
2+ years expTribute Technology is looking for Clinical Research Associates II to support clinical trials. The CRA II will be responsible for monitoring clinical trial activities, ensuring compliance with protocols and regulatory requirements, and preparing necessary documentation for audits and submissions.
Computer Software
Responsibilities
Oversee clinical trial activities at investigational sites (will require travel to investigational sites)
Conduct and write accurate visit reports in accordance with SOPs and GCP, including pre-study, site initiation, routine monitoring, and close-out visits
Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols
Ensure data entered on the CRFs by investigational sites is performed in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (SDV)
Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data
Monitor sites' completion of action items between visits
Prepare for audits and inspections
Participate in internal TMF reviews
Review and write informed consent forms
Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development
Prepare submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and assist in administrative tasks for submissions
Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements
Prepare annual trial progress reports for IRBs/ECs and CAs/FDA under supervision
(Assist in) reporting Serious Adverse Event to Sponsor, IRBs/ECs, CAs/FDA and investigators
Participate in project meetings and investigator meetings; write and publish minutes
Perform submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and follow-up until approval is obtained
Prepare clinical trial agreements and discuss/negotiate between site and Sponsor
Qualification
Required
B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience
Minimum 2-3+ years of prior CRA experience needed
Ability to understand basic and complex medical details
GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable; knowledge of regulatory regulations and guidelines on medical devices
Excellent planning and prioritizing skills with a strong client focus and the ability to flex with business needs. Results-oriented
Ability to travel up to 75-80% (includes overnight travel - on average, will travel 2-3 days per week, with up to 8 site visits per month)
Fluent English, good spoken and written communication skills
Preferred
Previous experience with medical device or medical technology studies strongly preferred
Benefits
Competitive compensation and benefits package (details shared during the interview process)
Training and other development opportunities
Company
Tribute Technology
At Tribute Technology, we help funeral professionals create meaningful, memorable experiences through innovative and thoughtful technology.
201-500 employees
H1B Sponsorship
Tribute Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Growth StageLeadership Team
Charlie Cole
Chief Executive Officer
Frances DeBlasio, MBA
Chief Financial Officer
Recent News
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