Site Management Associate II/Senior (In-House CRA) [Mexico]

 

At ICON, it’s our people that set us apart. 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.

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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 Site Management 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, multi-cultural, and multi-disciplinary.
• 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.

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.

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.

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 sessions.
• Keeps current on industry trends and regulations.

LEADERSHIP

• Self-motivated, developing organizational abilities for multi-tasking.
• Supports the LPOR management activities an initiatives.
• Supports the development and maintenance of practice-specific process documents (e.g., SOPs and Best Practice Guidelines).
• Supports team compliance with all relevant SOPs and Best Practice Guidelines

MANAGERIAL/ ADMINISTRATIVE.

• Practices good time management, with support.

ADAPTABILITY

• Demonstrates flexibility working across different time zones and working with internal and external teams.
• Able to adapt to changes in deadlines, competing project demands, and changes in the nature of assignments, with support.

PROBLEM-SOLVING

• Demonstrates resourcefulness and makes appropriate use of available technology and tools in seeking and implementing solutions.
• Works well with other individuals and departments to solve problems; begins to seek solutions proactively.

WORK QUALITY

• Consistently produces high-quality work, with support.

You will need:

• 1 year+ site management or strong understanding of remote monitoring in Clinical Trials
• Excellent written, and oral communication in English
• Working knowledge of MS office

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect the delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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