PRAHS

Returning Candidate?

2017-44186

2017-44186

Title 
Clinical Research Associate, Core Team - China
Job Locations 
-
China
Posted Date 
12/6/2017

More information about this job

Overview

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

At PRA Health Sciences, providing innovative solutions for our clients is what we do. PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

Responsibilities

  • Working fully as part of our Core Team and based at the PRA offices, the Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.

    With full ownership of investigator sites for your assigned studies, your involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, you will foster effective relationships with investigator site staff to ensure that key clinical metrics are met. This will involve establishing innovative ways of increasing site and patient recruitment. When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team. You may also design and deliver training to site staff, when appropriate.

    Typical duties will likely include preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues that have occurred at your site. You will ensure the integrity of clinical data through your ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.

    Through your ability to operate as a key part of a global study team, you will play a fundamental role in our client’s drug development process.

    Duties and Responsibilities (including but not limited to):

    • Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
    • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
    • Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
    • Provides regular site status information to team members, trial management, and updates trial management tools
    • Completes monitoring activity documents as required by PRA SOPs or other contractual obligations 
    • Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
    • Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
    • Performs essential document site file reconciliation
    • Performs source document verification and query resolution
    • Assesses IP accountability, dispensation, and compliance at the investigative sites
    • Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
    • Communicates with investigative sites
    • Updates applicable tracking systems
    • Ensures all required training is completed and documented
    • Serves as observation visit leader
    • Facilitates audit s and audit resolution
    • Mentors junior level CRAs and serves as a resource for new employees
    • Serves as observation  and performance visit leader
    • May be assigned  additional Clinical Operations tasks
    • May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
    • May be assigned clinical tasks where advanced negotiating skills are required

Qualifications

  • The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.

    Ideally we would like for you to have at least 1 year of monitoring experience.

    It is essential that you have prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements.

    Fluency in English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.

    We are looking for future colleagues in Beijing, Shanghai and Guangzhou.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Options

Share on your newsfeed

Connect With Us!

Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!