JOB SUMMARY

The Senior Clinical Research Associate (SCRA) is responsible for monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, sponsor requirements, and applicable regulatory standards. The SCRA serves as a primary liaison between investigative sites and the study team, supports study start-up and site management activities, conducts monitoring visits, utilizes electronic systems, reviews study documentation, and contributes to the successful execution of clinical trials.

RESPONSIBILITIES

• Review study protocols, Investigator Brochures, Clinical Monitoring Plans, and study-related documents to ensure a thorough understanding of study requirements and objectives.
• Conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with study protocols and approved Clinical Monitoring Plans.
• Assess investigator qualifications, site capabilities, patient populations, and facility resources to determine site suitability for study participation.
• Serve as the primary contact and resource for assigned investigative sites.
• Monitor source documentation, case report forms (CRFs), and electronic data capture (EDC) systems for accuracy, completeness, and protocol compliance.
• Perform source data verification (SDV) and source data review (SDR) in accordance with study and sponsor requirements.
• Verify informed consent documentation, subject eligibility, protocol compliance, and patient safety throughout the study.
• Identify, document, track, and follow up on protocol deviations, corrective and preventive actions (CAPAs), and site retraining activities, as required.
• Generate, review, and resolve data queries in collaboration with investigative sites, data management and study team members.
• Review adverse event documentation, investigational product accountability records, and other study-related documentation for accuracy and completeness.
• Monitor regulatory documentation and essential study records to ensure compliance with protocol requirements, GCP, and applicable regulations.
• Maintain study tracking tools, monitoring records, and regulatory documentation in accordance with sponsor and company requirements.
• Ensure investigative sites maintain adequate study supplies and resources to support study conduct along with awareness of vendors supporting each clinical study
• Maintain regular communication with site personnel regarding recruitment, enrollment, retention, and overall study progress.
• Identify site performance issues, compliance concerns, and study risks, and communicate findings to the Project Manager and study team in a timely manner.
• Prepare monitoring visit reports, follow-up letters, and other required study documentation within established timelines utilizing assigned trip report systems.
• Provide regular updates on study status, site performance, enrollment, and overall study progress to project teams and Clinical Operations management.
• Participate in investigator meetings, sponsor meetings, study team meetings, and training sessions, as required.
• Assist in the development and review of study documents, including CRFs, study manuals, tracking tools, and regulatory materials.
• Support the training and mentoring of Clinical Research Associates (CRAs) and investigative site personnel, as assigned.
• Assist with study start-up activities, including site feasibility assessments, site selection, and collection of essential documents.
• Contribute to departmental initiatives, quality improvement activities, process enhancements, and clinical operations best practices.
• Maintain awareness of industry trends, regulatory developments, and advancements in clinical research through ongoing professional development.
• Perform other duties as assigned, which may include trip report review.

  Salary range between $125,000 - $135,000.  Final compensation is based on skills, experience, location, and overall expertise.  

TRAVELING

Ability to travel approximately 60% to 80%, including overnight travel, as required to support assigned clinical studies and to attend company training meetings. 

• Bachelor's degree in Life Sciences, Nursing, or a related field; equivalent experience may be considered.
• Minimum of five (5) years of clinical monitoring experience, including direct monitoring experience in CNS clinical trials, within a pharmaceutical, biotechnology, contract research organization (CRO), or academic research environment.
• Demonstrated knowledge of the clinical drug development process, clinical trial conduct, regulatory requirements, and clinical monitoring practices.
• Strong knowledge of ICH-GCP guidelines and applicable FDA and international regulatory requirements.
• Experience with electronic data capture (EDC) systems, CTMS and eTMF systems and clinical trial documentation processes.
• Excellent verbal and written communication, organizational, time management, and interpersonal skills.
• Strong attention to detail and the ability to effectively prioritize and manage multiple responsibilities.
• Ability to work independently while collaborating effectively within a cross-functional team environment.
• Strong analytical, problem-solving, and critical-thinking skills.
• Certified Clinical Research Associate (CCRA) certification preferred but not required.