Clinical Research Associate

OPIS s.r.l. • Houston, TX

7d

About The Position

Clinical Research Associate (CRA) is responsible for coordinating and overseeing the execution of clinical studies and clinical investigations: identify, select, initiate and close-out appropriate investigational sites for clinical studies and clinical investigations.

Requirements

• Therapy Area Experience: Dermatology, Cardiology, Gastrointestinal Disorders
• Location: Dallas or Houston and/or surroundings
• University degree in a scientific/life science field
• At least 3 years of experience in managing and conducting clinical trials
• In depth knowledge of ICH GCP principles
• Able to carry out independently all the activities related to the monitoring of clinical trials
• Good knowledge of Office Suite (Word, Excel, PowerPoint)
• Organizational and problem-solving skills
• Excellent written and verbal communication skills including good command of English language
• No restrictions to travel onsite

Responsibilities

• Identify investigator sites and participate in the feasibility process for new studies
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCP
• Perform visits remotely according to foreseen applicable procedures and timeframes
• Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission
• Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets
• Check the correct submission and completion of informed consent forms
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
• Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures
• Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion
• 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

Benefits

• We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level