Country Study Specialist

Title: Country Study Specialist

 

Position Purpose:

The Country Study Specialist (CSS) is responsible for providing coordination and operational solutions to support Country Study Managers (CSMs). The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.

 

Main Responsibilities and Accountabilities:

  • Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring quality and safety standards, regulations, timelines and budget commitments are met.
  • Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable).
  • Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters.
  • Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.
  • Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures.
  • Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
  • Is responsible for the coordination and oversight of local affiliate study level audit/inspection audit action plan activities.
  • Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance.
  • Coordinates study or country communication plan.

 

Qualifications:

Bachelor’s degree or equivalent; professional qualification preferably in a medical/science-related field and experience demonstrating knowledge and understanding of clinical trials.

Monitoring experience is desirable.

Previous experience managing projects is desirable.

 

Competencies:

Managing Work – Effectively manages self-time and resources to ensure that work is completed efficiently.

Monitoring Information – Sets up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.

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.

Work Standards – Sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposes standards of excellence rather than having standards imposed.

Adaptability – Maintains effectiveness when experiencing major changes in work responsibilities or environment (e.g. people, processes, structure, or culture); adjusts effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful.

Building Partnerships – Develops and leverages relationships within and across work groups to achieve results.

Initiating Action – Takes prompt action to accomplish work goals; takes action to achieve results beyond what is required; is proactive.

Earning Trust – Gains others’ confidence by acting with integrity and following through on commitments while disclosing own positions; treats others and their ideas with respect and supports them in the face of challenges.

Decision Making – Identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative information; chooses the best course of action by establishing clear decision criteria, generates and evaluates alternatives, and makes timely decisions; takes action that is consistent with available facts and constraints and optimizes probable consequences.

Influencing – Uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.

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.

 

Other:

Availability to travel domestically and internationally, if required.

Ability to communicate clearly and accurately in both written and spoken English.

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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