Sr CRA 3 - (R1045119) in Riga, LV at IQVIA™

Date Posted: 10/29/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Riga, LV
  • Experience:
    At least 4 year(s)
  • Date Posted:
    10/29/2018
  • Job ID:
    R1045119

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity 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 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.



Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

 In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., 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

 Effective time management skills

 Ability to manage competing priorities

 Effective mentoring and training skills

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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

 Bachelor's degree in a health care or other scientific discipline or educational equivalent and 4 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

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.



Job ID: R1045119