Clinical Research Associate II/Sr. -FSP
Parexel
Hong Kong
3天前

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.

    Why Work at Parexel

    There are pivotal moments in every career : Sharing new treatments. Improving processes. Delivering life-saving advances.

    The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path?

    A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That’s Parexel. We’re a diverse team of professionals focused on one goal : getting treatments into the hands of those who need them most.

    Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

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