The CRA anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The CRA should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to all corrective action is taken at the clinical site and is properly documented.
Additional Job Responsibilities:
* Monitors activities conducted by clinical investigative sites/pharmacies as they relate to clinical studies to ensure successful execution of the protocol.
* The CRA conducts clinical site monitoring visits across multiple therapeutic areas, ensuring studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites/pharmacies.
* Conducts site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and the clients Health Standard Operating Procedures (SOPs) and business processes.
* Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and objectives. This includes but is not limited to:
o Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas.
o Review CRFs (paper or electronic) and subject source documentation for validity and accuracy
o Issues queries and track general findings from quality control reviews to identify trends and systemic issues.
o Appropriately reports and escalates serious or outstanding issues to manager as appropriate, as defined in the study monitoring plan.
o Verify adherence to the study protocol, SOPs, and relevant regulations, as well as good documentation practices (e.g., ALCOA+ principles)
o Overviews the overall activities of site/pharmacy personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
o Is proactive in managing the site/pharmacy and ensures action plans are put into place as needed to ensure compliance.
o Ensures quality of data submitted from study sites/pharmacies and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site/pharmacy personnel.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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High School Diploma and at least 5 years of CRA experience
Willing to travel up to/at least 50% of the time for business purposes (within state and out of state).
Clinical research monitoring experience
Decentralized/hybrid clinical trials experience
In-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
Knowledge of regulations governing clinical research, ICH/GCP Guidelines, US CFR, HIPAA and other applicable regulations
Experience in on-site/remote monitoring of investigational drug or device trials in accordance with company Standard Operating Procedures and FDA regulations is required
Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail
Experience with the review of CRFs (paper or electronic) and subject source documentation is a must
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.