Senior Clinical Research Associate
hace 3 semanas
At ICON, we pride ourselves on being a leader in the clinical research industry. Our team of experts is dedicated to advancing and improving patients' lives through clinical trials.
Key Responsibilities:
We are seeking a Senior Clinical Research Associate to join our team, who will be responsible for managing, implementing, and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs, and all applicable rules and regulations.
The Role Responsibilities:
- Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients, and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business, and meeting client needs.
- Serves as the primary contact for sites and investigators participating in studies.
- Acts as a resource for internal study teams and other ICON departments
- Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others), and other site management documents.
- Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan.
- Participates in QA audits as needed.
- Regularly attends and contributes to project-specific and departmental meetings
- Ability and willingness to travel as needed (drive and fly) - approximately 25% of the time.
- Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs.
- Maintains and archives study documentation and correspondence, as needed.
- Assists with site contracting process, as needed.
- Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed.
- With support, demonstrates the ability to manage site assignments and workload
- Maintains Sponsor and patient confidentiality.
- Actively participates in regular meetings with Project Managers or delegates, and/or RS
- LEAD
- Assists in the development of site and patient enrolment strategies with the project team; works to motivate sites to meet enrolment timelines.
- Developing knowledge of and compliance with local regulatory requirements
- Compliant and current with departmental and corporate policies and procedures.
Requirements:
- Excellent written and oral skills while showing cultural awareness and understanding; strong presentation skills, and proactive interaction with the study team and site staff.
- Demonstrates ability to provide and receive constructive feedback; appreciates team goals, respects other's point of view, and seeks advice when appropriate.
- Supports the formation of relationships with internal and external customers
- May attend bid defense presentations, as needed.
- Supports internal and external capabilities presentations.
- Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budgets.
- Follows departmental policies and procedures.
- Takes responsibility for project tasks and sees these tasks through to successful completion, with support.
- Completes special projects and miscellaneous assignments as needed to meet project and/or department objectives.
- Maintains professional interpersonal relationships with team, sites, and Sponsor.
- Increases knowledge of therapeutic areas, GCP, and any applicable local regulatory requirements.
- Seeks opportunities to demonstrate leadership and enhance own professional growth.
- Actively participates in Lunch and Learns, Journal Clubs, or other internal company training sessions.
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