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Clinical Research Associate II/Sr. -FSP

, Hong Kong SAR Date posted 05/09/2021 Job ID 66195BR

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.

As a CRA at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Innovative
  • Problem-Solver
  • Communicator
  • Tech-Savvy
  • Confident
  • Independent
  • "The last 4.5 years I had a steep learning curve and I am still learning via on-the-job challenges and solid management feedback. Next to my personal growth, I also enjoy our open atmosphere and the great collegiality."

    Stefanie – Sr Clinical Research Associate

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Compensation

    Competitive salaries and bonus structure based on individual metrics.

Responsibilities

Position Purpose:
• This position provides oversight of clinical research sites compliance with ICH/Good Clinical Practices (GCP), governing SOPs (standard operating procedures) and clinical study protocols.
Organizational Relationships:
• Day to day direction and project reporting is provided by Client and Clinical Study Manager (CSM)
• Interfaces with cross-functional study team members in a matrix environment

Primary Duties:
• Serves as the primary point of contact for assigned clinical research sites
• Performs site development and training (supporting and coaching site personnel), site set-up, site monitoring (evaluation of site performance and identification of issues), and site close-out activities for assigned clinical research sites with designated program SOPs, Client expectations, clinical study protocols and GCPs
• Problem solves (including CAPA development where necessary) identified issues with appropriate escalation to Client POC or Clinical Operations Manager and/or designees
• Assures protection of the rights, safety, and well-being of subjects, study integrity and data quality
• Performs activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, device accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution
• Facilitates the collection and maintenance of regulatory and site documentation for the Trial Master File and site file
• Manages Central and Local IRB or EC submissions including; workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB or EC in conjunction with study team/Client/site staff as applicable.
• Maintains awareness of site dynamics and able to motivate, persuade and educate site staff
• Complies with the Clinical Monitoring Plan and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the studies within the program
• Completes monitoring reports in compliance with requirements in the Clinical Monitoring Plan
• Completes training assigned by ExecuPharm/Parexel as applicable and/or the Client, as necessary, including general training requirements, SOPs, and system and process related training, and protocol specific training.
• Exhibits ability to proactively identify and interpret problems, recommend creative solutions, and influence appropriate changes
• May support more than one clinical study, as required
• Complies with all objectives and metrics related to study and program execution
• Attend meetings as requested (i.e. investigator, study, program) to gain and/or share program/study/site knowledge

Qualifications

Skills and Education (Qualifications):
• Bachelor’s Degree in Life Science or professional degree in life science/ medical background/equivalent expertise preferred
• Minimum 3+ years of monitoring experience
• 1 year medical device experience
• Orthopedic experience preferred
• Preferred EC submission and MediData RAVE experience
• Demonstrates solid understanding of clinical research practices
• Understands and is able to comprehend study protocols
• Possesses working knowledge of GCPs and other local country regulations governing clinical research
• Demonstrates technical expertise in computer skills
• Demonstrates diligent and self-motivated approach to working in an independent environment
• Demonstrates effective oral and written communication skills
• Ability to travel as required to meet program objectives
• Ability to speak, read and write in English

A little about us
Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.

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