FSP CRA (CRA I or II)

Overview

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.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Flexible
• Organized
• Problem-solver
• Self-starter

About This Role

FSP CRA opening (Global Pharmaceutical Company FSP Team) for CRA I or II level.

This role requires to go to Client's office 1-2 days a week.

Key Accountabilities

Maintenance (from initiation through close out):

• Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
• Build relationships with investigators and site staff.
• Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
• Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
• Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
• Address/evaluate/resolve issues pending from the previous visit, if any.
• Follow-up on and respond to appropriate site related questions.
• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
• Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
• Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
• Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Conduct remote visits/contacts as requested/needed.
• Generate visit/contact report.
• Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
• Assess & manage test article/study supply including supply, accountability and destruction/return status.
• Review & follow-up site payment status.
• Follow-up on CRF data entry, query status, and SAEs.
• Conduct on-site study-specific training (if applicable).
• Perform site facilities assessments
• Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

Overall Accountabilities from Site Identification to Close out:

• Ensure timely and accurate completion of project goals and update of applicable trial management systems.
• Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
• Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
• Ensure that assigned sites are audit and inspection ready
• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
• Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
• Show commitment and perform consistent high-quality work.
• Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
• Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
• Provide input and feedback for Performance Development Conversation(s).
• Proactively keep manager informed about work progress and any issues.
• Develop expertise to become a subject matter expert.
• Work in a self-driven capacity, with limited need for oversight.
• Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Skills

• Sound problem solving skills.

• Able to take initiative and work independently, and to proactively seek guidance when necessary.

• Advance presentation skills.

• Client focused approach to work.

• Ability to interact professionally within a client organization.

• Flexible attitude with respect to work assignments and new learning.

• Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.

• 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.

• Strong interpersonal, verbal, and written communication skills.

• Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.

• Effective time management in order to meet study needs, team objectives, and department goals.

• Developing ability to work across cultures.

• Shows commitment to and performs consistently high-quality work.

• Ability to successfully work in a (‘virtual’) team environment.

• Consulting Skills

• Great attention to detail.

• Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.

• Holds a driver’s license where required.

• Knowledge and Experience

• Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

Education

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

• Potential Career Path

• Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.

• APEX CRA

• CRA I

• CRA II

• Senior CRA

• Project Management

• Subject Matter Expert

• People Management

• Employee Insights

• Nick on a day in a life of a CRA

• Nick Burger | Senior Clinical Research Associate

• Watch Video

• Liliana on CRA tasks and our recognition program

• Liliana Belmares Flores | CRA Line Manager

• Watch Video

• Marlayna on why Parexel is a great place for CRAs

• Marlayna Fitts | CRA Line Manager

• Watch Video

• TEAM IMPRESSIONS

• Why Clinical Research Associates work at Parexel

• Patient-focused in everything we do

• We push the boundaries of what is possible to create clinical trials that are inclusive, innovative, and patient-focused

• Supportive and inclusive environment

• We foster collaboration, teamwork, respect, and inclusivity, to work together to achieve common goals.

• Career growth and development

• We develop your skills through training, mentorship, and career advancement programs.

• Flexible work arrangements

• We focus on outputs and results, not where and when you work.

• Diverse therapeutic areas and project exposure

• We continuously learn from a broad exposure from early to late phase clini