Senior Clinical Research Associate Cns

Senior CRA – Dallas Area C-Clinical is hiring a Senior Clinical Research Associate (CRA) with experience in CNS, oncology, or metabolic indications to join our growing team in the Dallas area. This is a hybrid role that combines remote, risk-based monitoring with on-site visits as needed. We’re looking for experienced professionals who are passionate about advancing clinical research and ready to make an impact. The ideal candidate is proactive, detail-oriented, and brings a strong understanding of regulatory requirements, site engagement, and protocol compliance. At C-Clinical, we’re committed to doing life-changing work—and we want to grow alongside like-minded individuals who share that purpose. Our team thrives on collaboration, integrity, and a deep sense of mission in every study we support. If you're a skilled CRA based in or around Dallas and ready to be part of a dedicated and mission-driven research team, we’d love to hear from you. Apply today, and please complete the brief intro survey sent via email after submission. 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 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 in-patient 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 working rights 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% 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