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The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.
Primary Responsibilities
- Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out.
- Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
- Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.
- Verifies proper management and accountability of Investigational Product (IP).
- Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
- Manages essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study; assists with resolution of investigational site/data queries.
- Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
- Participates in audit preparation and follow-up activities as needed.
Senior Clinical Research Associate
- Independently performs a wide variety of onsite and offsite monitoring visit types.May be assigned studies tharequire complex therapeutic knowledge.
- Serves as a preceptor, providing training and coaching feedback to less experienced clinical team
members.
- Gathers and reviews information for assigned sitesand identifies inconsistencies.
Independently assesses riskand escalates as applicable.Provides corrective and preventative actions.
- Assists with ad hoc, short
- term assignments in support of study or departmental initiatives with mínimal management support.
- May be assigned clinical tasks where advanced negotiating skills are required.
Knowledge,Skills and Abilities
- Advanced knowledge of the drug development process
- Advanced knowledge and practical utilization of ICH- GCP and applicable regulatory requirements
- Sound knowledge of applicable policies and procedures, SOPs, work instructions and other guidance documents
- Excellent spoken and writtencommunication skills; excellent presentation skills
- Advanced interpersonal, collaboration and time management skills
- Advanced skill in utilization of applicable clinical systems
- Advanced critical thinking skills
- Excellent organizational skills
- Ability to focus on detail for extended periods of time; high attention to accuracy
- Ability to travel extensively
- Ability to establish and maintain effective working relationships with investigative site staff
- Good negotiation skills
Problem Solving
Problems are differing but related. Solutions are not readily apparent. Undertakes analysis and investigation to identify and define problems. Work is done independently, reviewed at critical points.
Interaction
Adapts style and uses persuasion in delivering messages. Issues may be complex, audience perspectives may be divergent, and information may be non-routine in nature.
Impact
Contributes to the achievement of goals through personal effort and influence over others.
Impact is focused on the achievement of short
- to medium-term goals.
Physical requirements
Travel is required 50-80%
Minimum education
Undergraduate degree or international equivalent in clinical, science, or health
- related field from an accredited institution; health care professional licensure, i.e., registered nurse
Minimum experience
4 years of experience supporting clinical trials including 3 years of on-site monitoring experience
**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed t
