Associate Clinical Research Associate - FSP

Job Purpose:
The Role for Associate Clinical Research Associate (ACRA) has been created in Parexel to train and develop people, without any experience in clinical research. During the training period (minimum 6 months), ACRA is responsible for learning and developing skills and competencies to work in a clinical research environment. At the end of this period the ACRA would be ready to work independently within Global Clinical Operations Department in Parexel.

• Attend all training activities organized for this role (in the country or at international level)
• Complete all mandatory trainings in LMS
• Do all pre-work that applies to each training activity
• Complete and deliver on time all activities including post-training activities
• Attend all on-going, relevant trainings, including Continuing Education Workshops (CEW) that are applicable
• Learn to work in compliance with ICH-GCP Guidelines, applicable international and local regulations, Parexel SOPs, other Parexel and study specific procedures and requirements
• Show commitment and consistently perform high quality work

• Learn to build relationships with investigators and site staff, including participation in calls with sites
• Be able to identify and understand essential documents required for a clinical trial
• Be present and support all start-up activities including EC/IRB
• Understand the submission process for Site Regulatory Package (SRP) documents collection and follow-up
• Being involved in issue identification, follow-up and resolution.
• Be able to identify and evaluate potential quality issues.
• Attend remote observational visits as requested
• Learn about the practical use of the Clinical Trial Management System (CTMS) and any other relevant internal systems

• Arrange on-site observational visits and logistics (e.g. travel arrangements).
• Perform on-site observational visits (Qualification, Initiation, Monitoring and Termination) with appropriate support; apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Work with the mentor in the visit report and follow up letters writing activities.

• Successfully pass all assessments related to this role
• Complete routine departmental administrative tasks in a timely manner (e.g. times, metrics, concur etc.)
• Attend to all internal activities and corporate meetings

• Perform project specific training agreed to understand the main project activities
• Ensure the basic understanding of project scope, milestones,budgets, and time codes and strive for high quality, timely, and efficient delivery
• Help the local team in completing Clinical Trial Management Systems (CTMS) and study specific trackers
• Track, scan, code and apply naming convention and send documents to the relevant study e-CF Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan, if applicable
• Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP) if applicable
• Assist with the creation and completion of the Investigator Site File if applicable
• Support in on-site / remote visits preparation and follow-up if applicable

Skills:
• Ability to interact professionally within a client organization with the support of manager or team members
• Flexible and positive attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm
• Attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork

• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
• Sound interpersonal, verbal, and written communication skills
• Sound proactive and problem solving skills
• Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables
• Effective time management in order to meet daily metrics, team objectives, and department goals
• Shows commitment to and performs consistently high quality work
• Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned
• Willing and able to travel locally and internationally occasionally as required.
• Holds a driver’s license where required.

Knowledge and Experience:
• Previous relevant work experience valuable
• Proficient in written and oral English and fluent in relevant local language

Education:
• Educated to degree level (biological science, pharmacy or other health-related discipline preferred) or equivalent nursing qualification

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.