Senior CRA

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.

Recognize, exemplify and adhere to ICON's values, which center on 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.
• Positive attitude towards their position and ICON
• 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
• Supports the Research Services Department by applying critical thinking about the business needs of a study and/or Site Management activities
• Participates in QA audits as needed
• Regularly attends and contributes to project specific and departmental meetings
• Assists, as needed, in developing and reviewing study documents
• 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
• Assists with SAS/Steering Committee organization and attendance when applicable
• Demonstrates increasing ability to manage site assignments and workload
• Maintains Sponsor and patient confidentiality
• Actively participates in regular meetings with Project Managers or delegate, and/or RS Lead to discuss project strengths and challenges associated with recruitment, enrolment, site communications and site responsiveness
• Assumes additional responsibilities as detailed and documented by PM or delegate, RS Lead or Line Management
• Assists in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines
• Demonstrates ability to implement the study monitoring plans/metrics as appropriate and agreed upon
• Working 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, proactive interaction with study team and site staff
• Demonstrates ability to provide and receive constructive feedback; appreciates team goals, respects others point of view and seeks advice when appropriate

BUSINESS DEVELOPMENT

• Supports and fosters relationships with internal and external customers
• May support the development of proposals for new business and attend bid defence presentations
• May attend bid defence presentations, as needed
• Supports internal and external capabilities presentations

TEAMWORK

• Participates in training and mentoring of junior staff
• Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budget
• Supports and follows departmental policies and procedures
• Takes responsibility for project tasks and sees these tasks through to successful completion
• 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

• Continues to increase knowledge of therapeutic areas, GCP and any applicable local regulatory requirements
• Continues to seek more 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

• Highly self-motivated, strong organizational abilities for multi-tasking
• Supports the LPOR management activities and 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

• Helps to ensure project activities are consistent with project requirements and scope
• 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
• Ability to work independently with minimal direction; successfully handles increasingly complex tasks/assignments

PROBLEM SOLVING

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

WORK QUALITY

• Consistently produces high-quality work, with support