As a Clinical Research Monitor you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
**What you will be doing**:
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, and 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 the 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.
- Independently performs a limited range of onsite and offsite monitoring visit types.
- Gathers and reviews information for assigned sites and identifies inconsistencies. With guidance from project and functional management, assesses risk and escalates as appropriate.
- Independently performs a variety of onsite and offsite monitoring visit types.
- Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
- Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
- May serve as preceptor, providing training to less experienced clinical team members.
**You are**:
- 3 years of experience supporting clinical trials including 3 year of on-site monitoring experience
- In-depth knowledge of the drug development process
- In-depth 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
- Good spoken and written communication skills; good presentation skills
- Strong interpersonal, collaboration and time management skills
- Excellent skill in the utilization of applicable clinical systems
- Excellent 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 s
**Why ICON?**
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.