• CRA 1.. Jobs in China - 25367251

  • Iqvia
  • China
  • Save Job
  • 3 - 6 Years
  • Posted : above 1 month

Job Description:

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward



PURPOSE

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice If applicable, Senior Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability

RESPONSIBILITIES

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice

If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability

Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations Escalate quality issues - as appropriate

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution May support project/site start-up phase

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation

Act as a mentor for new clinical staff for clinical staff including conducting co-monitoring and training visits

May provide assistance with design of study tools, documents and processes

Convey features and opportunities of study to site

Collaborate and liaise with study team members for project execution support as appropriate

All responsibilities are essential to job functions unless noted as non-essential (N)

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

In depth therapeutic and protocol knowledge as provided in company training

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

Strong written and verbal communication skills including good command of English language

Excellent organizational and problem-solving skills

Strong time management skills

Ability to manage competing priorities

Good mentoring and training skills

Ability to establish and maintain effective working relationships with coworkers, managers and clients

Page 2

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelors degree in a health care or other scientific discipline or educational equivalent and 3 years of on-site monitoring experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

Extensive use of telephone and face-to-face communication requiring accurate perception of speech

Extensive use of keyboard requiring repetitive motion of fingers

Regular sitting for extended periods of time

Requires frequent travel to sites

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage It takes brave minds, pushing the boundaries to transform healthcare Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients

Forge a career with greater purpose, make an impact, and never stop learning

Job ID R1092584

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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