ICON Strategic Solutions · 5 hours ago
Clinical Research Associate
California, United States
Full-time
Hybrid
Mid, Senior Level
2+ years expICON Strategic Solutions is seeking a Clinical Research Associate II to join their diverse and dynamic team. In this role, you will design and analyze clinical trials, ensure protocol compliance, and collaborate with investigators to facilitate study conduct.
Hiring Manager
Christine Kuebler
Responsibilities
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Ability and willingness to travel at least 60% of the time (international and domestic : fly and drive)
Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations
Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems
Recruitment of investigators
Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following: Identify investigators
Help when requested, in preparation of regulatory submissions. Design of patient information sheets and consent forms
Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate
Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs
Keep the Project Manager regularly informed
Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner
Ensure the satisfactory closeout of investigator sites
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report
Participate in feasibility studies for new proposals as required. Ensure correct archiving of files on completion of a study
Maintain patient and sponsor confidentiality
Assume additional responsibilities as directed by the Project Manager
Ensure storage conditions and acceptable supplies are provided
Ensure IPs are supplied only to eligible patients
Ensure IP receipt, use and return are controlled and documented
Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor
Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate
Participate in data listing reviews, as applicable
Responsible for cost effectiveness
Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate
Assist with marketing the company if and when appropriate
Other duties as assigned
Qualification
Required
Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations
Familiarity with ICON systems
Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems
Recruitment of investigators
Independent and proactive coordination of all the necessary activities required to set up and monitor a study
Identify investigators
Help when requested, in preparation of regulatory submissions
Design of patient information sheets and consent forms
Ensure timely submission of protocol/consent documents for ethics/IRB approval
Pre study/placement and initiation visits
Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate
Maintain all files and documentation pertaining to studies
Motivate investigators in order to achieve recruitment targets
Complete accurate study status reports
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs
Keep the Project Manager regularly informed
Process case record forms to the required quality standards and timelines
Deal with sponsor generated queries in a timely manner
Ensure the satisfactory closeout of investigator sites
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report
Participate in feasibility studies for new proposals as required
Ensure correct archiving of files on completion of a study
Maintain patient and sponsor confidentiality
Assume additional responsibilities as directed by the Project Manager
Ensure storage conditions and acceptable supplies are provided for investigational Products (IPs)
Ensure IPs are supplied only to eligible patients
Ensure IP receipt, use and return are controlled and documented
Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor
Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate
Participate in data listing reviews, as applicable
Responsible for cost effectiveness
Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate
Assist with marketing the company if and when appropriate
Other duties as assigned
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions 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
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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