Senior Clinical Research Associate - Cns

C-Clinical Dallas

Senior Clinical Research Associate - Cns

Dallas, TX
Paid
  • Responsibilities

    C-Clinical is looking for an experienced Senior Clinical Research Associate (CRA) to support clinical studies in the Dallas area. This hybrid opportunity combines remote, risk-based monitoring with on-site visits as needed, supporting study quality and effective site oversight. Professionals with experience in CNS, oncology, or metabolic indications are encouraged to apply. A strong understanding of regulatory requirements, protocol compliance, and site engagement is essential, along with attention to detail and the ability to identify and address study needs proactively. Our team values collaboration, integrity, and a shared commitment to advancing clinical research. You will work with dedicated professionals who bring care and accountability to the studies they support while contributing to research with the potential to improve lives. If you are a skilled CRA based in or around Dallas and value purposeful work within a collaborative research team, we would like to connect with you. Apply today, and please complete the brief introductory survey sent by email after submitting your application. Responsibilities: Sr. CRA – Dallas Area (On-site/Hybrid) Interfaces with the study team to ensure the timely initiation and completion of clinical trials Responsible for the identification, evaluation, and qualification of investigators and sites in the Dallas area and surrounding region May prepare and submit essential document packages required for clinical site initiation Performs on-site monitoring activities for clinical trials and escalates site issues to Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondence Reviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targets May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance Ensures the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements Identifies, tracks, and follows up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensures all applicable SAEs are reported to sponsor and regulatory authorities Ensures 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. Monitors the study database for missing or discrepant data compared to the source record at the clinical site Ensures that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan) Maintains the study blindly and acts as a blinded study monitor. Conducts eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision Attends investigators’ meetings, project team meetings, and teleconferences, as needed Understands and applies knowledge regarding local, state, and country regulations (e.g., FDA, ICH-GCP) Maintains training on ICH-GCP, study protocol, and internal procedures May track regulatory documents, monitor recruitment, evaluate study site quality and integrity, and help motivate assigned sites to meet timelines and performance expectations Qualifications: 3 years or more as a CRA with site monitoring responsibility and 1 year or more in CNS Or 3 years or more as a CRA with site monitoring responsibility and 1 year or more in either: Phase 1, a complex indication with inpatient monitoring, or metabolic studies Or 3 years or more as a CRA with site monitoring responsibility and 1 year or more in Oncology Monitoring And The candidate possesses a 4-year university degree, ideally in a scientific field In lieu of a 4-year university degree, a candidate with 7 or more years of relevant clinical research experience, nursing/possibly another medical certification, and 5 years of monitoring in a complex indication (inpatient, oncology, phase 1, etc.) may be considered Must have work authorization in the United States Must be located within the greater Dallas area The candidate must have availability for at least 1 year Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology Bilingual is a plus Corp to Corp Must be proficient at tactfully managing intra-team communication, as well as interpersonal communication Note: the travel rate is 50% of the regular rate Compensation: $65 - $95 hourly

    • Sr. CRA – Dallas Area (On-site/Hybrid) • Interfaces with the study team to ensure the timely initiation and completion of clinical trials • Responsible for the identification, evaluation, and qualification of investigators and sites in the Dallas area and surrounding region • May prepare and submit essential document packages required for clinical site initiation • Performs on-site monitoring activities for clinical trials and escalates site issues to Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondence • Reviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targets • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance • Ensures the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements • Identifies, tracks, and follows up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensures all applicable SAEs are reported to sponsor and regulatory authorities • Ensures 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. Monitors the study database for missing or discrepant data compared to the source record at the clinical site • Ensures that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan) • Maintains the study blindly and acts as a blinded study monitor. Conducts eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision • Attends investigators’ meetings, project team meetings, and teleconferences, as needed • Understands and applies knowledge regarding local, state, and country regulations (e.g., FDA, ICH-GCP) • Maintains training on ICH-GCP, study protocol, and internal procedures • May track regulatory documents, monitor recruitment, evaluate study site quality and integrity, and help motivate assigned sites to meet timelines and performance expectations