Senior Clinical Research Associate/Clinical Research Associate - All US Locations - FSP

About the role

The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

Key Accountabilities

• Site Management Responsibilities
• Compliance with Sponsor Standards
• Compliance with Parexel Standards

Skills

• Essential: Excellent attention to detail, good written and verbal communication skills, good collaboration and interpersonal skills, good negotiation skills, proficient in written and spoken English language, fluency in local language(s)
• Desirable: Ability to work in an environment of remote collaborators, manages change with a positive approach, ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time, good analytical and problem-solving skills, demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines, ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment, team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Knowledge and Experience

• Essential: Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, good knowledge of relevant local regulations, good medical knowledge and ability to learn relevant Client Therapeutic Areas, basic understanding of the drug development process, good understanding of Clinical Study Management including monitoring, study drug handling and data management
• Desired: Familiar with risk-based monitoring approach including remote monitoring, good cultural awareness

Education

A Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.