Senior Clinical Research Associate

1 week ago

Miami, Florida, United States C-Clinical at Miami Full time
Job Overview

We are seeking a highly skilled Senior Clinical Research Associate specializing in CNS for our expanding clinical research organization. This role is ideal for candidates with over three years of experience in clinical research, particularly those who are currently residing in Florida.

Compensation: $65 - $90 per hour

Key Responsibilities
  • Conduct on-site monitoring visits as required, ensuring compliance with study protocols.
  • Collaborate with the study team to facilitate the timely initiation and completion of clinical trials.
  • Identify, evaluate, and qualify clinical investigators and study sites.
  • Prepare and submit essential documentation for clinical site initiation.
  • Perform comprehensive on-site monitoring activities, documenting findings and escalating issues as necessary.
  • Manage and review data both on-site and remotely, addressing discrepancies to meet database targets.
  • Oversee all aspects of study site monitoring, including pre-study, initiation, routine, and close-out visits.
  • Ensure the protection of research subjects by adhering to informed consent procedures and regulatory requirements.
  • Track and report all Adverse Events (AEs) and Serious Adverse Events (SAEs) to the appropriate parties.
  • Guarantee the accuracy and integrity of data collected through meticulous source document review.
  • Conduct eCRF/CRF reviews and generate queries as needed.
  • Participate in investigators' meetings and project team discussions.
  • Maintain knowledge of local, state, and country regulations, including ICH-GCP guidelines.
  • Stay updated on training related to ICH-GCP and study protocols.
Qualifications
  • A minimum of three years of experience as a CRA with site monitoring responsibilities.
  • Experience in CNS or complex indications with in-patient monitoring is preferred.
  • Bilingual proficiency in Spanish and English is advantageous.
  • A four-year university degree in a scientific discipline is required.
  • Must possess valid working rights in the United States.
  • Located in Florida, within proximity to an airport.
  • Exceptional verbal communication skills and problem-solving abilities using medical terminology.
  • Strong interpersonal skills for effective team communication.
About C-Clinical

C-Clinical at Miami is dedicated to providing specialized consulting services in the pharmaceutical, biotechnology, and medical device sectors. Our mission is to foster meaningful relationships and guide our clients through the complexities of clinical research. We are committed to conducting impactful medical research and utilizing our expertise to support those in need.

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