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Regional CRA/Sr. CRA (Science & Biotech)
Dallas, TX 75201
Recruited by: Cody Jacinto | Sr. Recruitment Consultant | DOCS Global See all my Jobs

  • Hiring Company: DOCS Global
  • Industry: Science & Biotech
  • Compensation: $Competitive Compensation
  • Expires: Oct 21, 11
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Job Description

PURPOSE
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic
areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures,
good clinical practice, and applicable regulatory requirements.
RESPONSIBILITIES
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good
clinical practice.
• 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 to Clinical Team Lead (CTL) and/or line manager.
• 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.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by
submitting regular visit reports and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• May provide assistance to the CTL with design of study tools, documents and processes.
All responsibilities are essential job functions unless noted as nonessential (N).
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 Harmonisation (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 2 years of on-site
monitoring experience; or equivalent combination of education, training and experience