Senior Clinical Research Associate
7 days ago
C-Clinical at Dallas is a clinical operations partner that provides highly specialized consulting services for the pharmaceutical, biotechnology, and device industries. We are seeking a Senior Clinical Research Associate (CRA) to join our team in a CNS role.
Responsibilities- Interface with the study team to ensure timely initiation and completion of clinical trials
- Responsible for the identification, evaluation, and qualification of investigators and sites
- Prepare and submit essential document packages required for clinical site initiation
- Perform on-site monitoring activities for clinical trials and escalate site issues to Clinical Trial Manager (CTM)/Project Manager (PM); document activities in the monitoring reports and follow-up correspondence
- Review and manage data on-site and remotely; resolve issues on a continuous basis to achieve timely database targets
- Ensure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Identify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities
- Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor the study database for missing or discrepant data compared to the source record at the clinical site
- Ensure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan)
- Maintain study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision
- Attend investigators' meetings, project team meetings, and teleconferences, as needed
- 3 years or more as a CRA with site monitoring responsibility And 1 year or more CNS
Or
- 3 years or more as a CRA with site monitoring responsibility And 1 year or more in a complex indication with in-patient monitoring
Or
- 3 years or more as a CRA with site monitoring responsibility And bilingual in Spanish And English
And
- The candidate possesses a 4-year university degree, ideally in a scientific field
- Must have working rights in the United States
- Must be located in TEXAS, within 1 hour of an airport
- The candidate must have availability for this contract for September-December 2024. No promise of renewal
- Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology
- Bilingual is a plus
- Must be proficient at tactfully managing intra-team communication, as well as interpersonal communication
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