Country Study Coordinator

Mission:
Coordinate research through all phases of study (preparation, study start-up, conduct, close-out) and associated activities in collaboration with clinical operations stakeholders, in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments.
Main Responsibilities and Accountabilities:
Updates knowledge on related regulatory requirements, ensure adherence and compliance with local regulations and internal procedures.
Assists in project planning country/study level (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system.
Executes all start-up activities prior to the site activation on assigned studies, according to Roche standards and aligned with study/project requirements and timelines.
Acts as point of contact for Contract Research Organization (CRO).
Partners with Clinical Study Managers (CSMs) to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
Assist study feasibility, site-monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Roche studies.
General (Mandatory):
Attend / complete all requisite on-line and F2F trainings (Role specific, Safety responsibilities and Compliance) within specified timelines.
Identify, collect and immediately report all safety related information on Roche products to Local Safety Responsible as per Roche requirements and local regulations
Adhere to Roche policies and both global & local procedures.
Qualifications:
University degree or equivalent; preferably in a medical/science/pharmacist-related field.
Experience and Knowledge:
Experience in clinical research/development or related industry.
Demonstrate knowledge and understanding of clinical trials.
Demonstrate knowledge and understanding of International Council for Harmonization of Technical.
Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements forng clinical trials in the relevant country.
Skills and Competencies:
Decision Making - identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints, and optimizes probable consequences.
Planning and Organizing (Achieving Results/Strategic Agility) - establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources.
Communication - conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.
Building Partnerships (Teamwork and Collaboration) - develops and leverages relationships within and across work groups to achieve results.
Influencing (Inspiring and Influencing) - uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
Customer Orientation (Technical & Business Expertise) - places a high priority on the internal or external customer's perspective when making decisions and taking action; implements service practices that meet the customer's and own organization's needs.
Coaching (Feedback and Coaching) - engages individuals in developing and committing to an action plan that targets specific behaviours, skills, or knowledge needed to ensure performance improvement or prepare for success in new responsibilities.
Work Standards - sets high standards of performance; assumes responsibility and accountability for successfully completing assignments or tasks;
Innovation - creates novel solutions with measurable value for existing and potential customers (internal or external); experiments with new ways to solve work problems and seizes opportunities that result in unique and differentiated solutions.
Technical/Professional Knowledge and Skills - has achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position -related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.