Parexel is currently seeking an Associate Clinical Research Associate (CRA) – FSP in the United States. This role involves monitoring clinical trials to ensure compliance with protocols, Good Clinical Practice (GCP), and regulatory requirements.
Associate Clinical Research Associate – FSP
United States of America,
Job Type : Remote
Job ID : R0000029513
Category : Clinical Trials
As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs’ priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.
Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.
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 required for Associate Clinical Research at Parexel :
• Educated to degree level (biological science, pharmacy or other health-related discipline preferred) or equivalent nursing qualification