[Remote] Senior Clinical Research Associate, Sponsor-dedicated (Contract)

Note: The job is a remote job and is open to candidates in USA. Premier Research is seeking a Senior Clinical Research Associate to support its Functional Services Provider team. The role conducts clinical trial site monitoring and source verification, resolves data and compliance issues, manages study and site documentation, and negotiates site budgets.

Responsibilities

• Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records
• Issues, investigates, and resolves any data discrepancies identified during source verification activities
• Maintains thorough documentation and proper escalation of issues related to visit reports
• Ensures any identified non-compliance issues are addressed
• Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations
• Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database
• Performs budget negotiations with clinical trial sites

Skills

• Experience in Neurology or Psychiatry, including work with Schedule I controlled substances, is required
• 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, must have proven experience in all primary job functions
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials
• Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience

Benefits

• Remote work arrangement

Company Overview

Company H1B Sponsorship