Senior Clinical Research Associate
hace 2 semanas
Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity.
We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touchpoint.
In short, to be the partner of choice in drug development.That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us.
You'll be working in a dynamic and supportive environment, with some of the brightest and friendliest people in the sector, and you'll be helping shape an industry.
What will you be doing?
The Remote Clinical Research Associate is 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 responsibilities of this position include but are not limited to identifying, training/initiating, and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed, conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained.
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.
- Ability to work on study teams that are often virtual, multicultural, and multidisciplinary.
- 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 projectspecific and departmental meetings
- 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
- 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
COMMUNICATION
- 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.
BUSINESS DEVELOPMENT
- supports the formation of relationships with internal and external customers
May attend bid defense presentations, as needed.
- Supports internal and external capabilities presentations.
TEAMWORK
- Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budgets.
- Follows departmental policies and procedures.
- Completes special projects and miscellaneous assignments as needed to meet project and/or department objectives.
- Maintains professional interpersonal relationships with team, sites, and Sponsor.
PERSONAL/PROFESSIONAL DEVELOPMENT
- 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 se
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