Sr CRA (Fixed)

Senior Clinical Research Associate (Sr CRA)

This Senior Clinical Research Associate role focuses on late-phase (IIIII) clinical trials in central nervous system CNS or Oncology indications. You will work primarily from home while conducting regular on-site monitoring visits to ensure that clinical trials comply with Good Clinical Practice (GCP), applicable local and international regulations, and Standard Operating Procedures. The position involves independent site management, comprehensive monitoring of patient safety and data quality, and close collaboration with investigators and site staff to support the successful execution of complex CNS studies.

Responsibilities

• Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits in accordance with GCP, applicable regulations, and Standard Operating Procedures.
• Work independently during on-site monitoring visits to assess site performance, guide site staff, and make decisions on actions needed to maintain compliance and data integrity.
• Verify informed consent documentation to ensure all study participants have properly provided consent in line with protocol and regulatory requirements.
• Review and document serious adverse events, ensuring that reporting requirements are met and that safety information is complete and accurate.
• Identify, review, and document protocol deviations, and confirm that required submissions to institutional review boards or ethics committees are completed as needed.
• Review drug accountability logs to confirm correct handling, storage, dispensing, and return of investigational products.
• Conduct source document verification to confirm compliance with the protocol, protect patient safety, and ensure the accuracy and veracity of clinical data.
• Review case report forms using paper or electronic data capture systems and assist sites in resolving data queries to ensure complete and accurate data entry.
• Compile, review, and ensure completeness of regulatory documents and ethics submission documentation, including institutional review board or ethics committee approvals and informed consent materials.
• Coordinate the shipment and receipt of study materials such as case report forms, study manuals, and other trial-related documentation to and from study sites.
• Review subject eligibility against inclusion and exclusion criteria, monitor subject withdrawals, and ensure newly identified serious adverse events are reviewed and reported appropriately.
• Assess and document the conduct of site staff and the adequacy of site facilities to ensure ongoing compliance with ICH/GCP and study requirements.
• Review the regulatory binder at each site to ensure all required documents are present, accurate, and up to date.
• Address outstanding action items from previous monitoring visits and document their resolution clearly and comprehensively.
• Discuss study progress with principal investigators and study coordinators, including recruitment status, data quality, protocol adherence, and any outstanding issues.
• Maintain regular communication with study sites to provide guidance, follow up on issues, and support successful study conduct.
• Prepare detailed site visit reports that clearly document findings, issues, and required corrective actions, ensuring sites meet compliance with GCP and applicable regulations.
• Review study subject safety information and informed consent documentation to ensure ongoing compliance and participant protection.
• Perform other related duties as assigned, recognizing that the listed responsibilities represent the typical nature and level of work but are not exhaustive.

Essential Skills

• Minimum of a high school diploma or equivalent.
• At least 2 years of field monitoring experience as a Clinical Research Associate or in a similar clinical monitoring role.
• Demonstrated experience conducting on-site monitoring visits, including qualification, initiation, interim monitoring, and close-out activities.
• Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Experience in CNS OR Oncology clinical research, such as psychiatry, neurology, schizophrenia, major depressive disorder, or related therapeutic areas.
• Proficiency in clinical monitoring activities, including source document verification, drug accountability, and protocol compliance review.
• Ability to review and manage serious adverse events and protocol deviations in accordance with regulatory requirements.
• Experience working with paper and electronic data capture systems for case report form review and query resolution.
• Ability to compile and review regulatory documents and ethics submissions, including institutional review board or ethics committee approvals and informed consent forms.
• Strong written communication skills for preparing clear, comprehensive site visit reports and documentation.
• Effective verbal communication and interpersonal skills to collaborate with investigators, coordinators, and site staff.
• Ability to work independently in the field, make sound decisions during site visits, and provide clear direction to clinical research sites.
• Willingness and ability to travel within the assigned region and occasionally beyond as needed for site visits.

Additional Skills & Qualifications

• Familiarity with pharmacoeconomic or observational research components within clinical studies.
• Experience working with mid-size contract research organizations or similar environments.
• Ability to manage multiple sites and studies simultaneously while maintaining high standards of quality and compliance.
• Strong organizational skills and attention to detail in managing documentation, timelines, and follow-up actions.
• Comfort working under long-term contract arrangements with potential for renewal based on performance and project needs.

Work Environment

This position is primarily home-based, offering a remote work environment with regular regional travel for on-site monitoring visits. Clinical Research Associates typically conduct a minimum of eight on-site days per month, with most sites located within approximately six hours or less for round-trip travel. The role involves working with electronic data capture systems, regulatory documentation, and clinical trial materials in a professional, compliance-focused setting. You will collaborate closely with investigators, study coordinators, and cross-functional clinical teams while operating independently during site visits. Contracts are structured as long-term, renewable engagements, providing continuity and the opportunity to support multiple CNS studies over time.

Job Type & Location

This is a Contract position based out of Houston, TX.

Pay and Benefits

The pay range for this position is $75.00 - $85.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jul 3, 2026.