Job Description

Position Summary

The Clinical Research Associate (CRA) is responsible for monitoring clinical trial sites to ensure studies are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. The CRA acts as the primary point of contact between the sponsor/CRO and investigative sites, safeguarding data integrity and patient safety throughout the trial lifecycle.

Essential Duties and Responsibilities

• Conduct site selection, initiation, routine monitoring, and close-out visits in accordance with the monitoring plan
• Verify informed consent procedures and confirm patient rights and safety are protected throughout the trial
• Perform source data verification (SDV) and source data review (SDR) to ensure accuracy and completeness of case report forms (CRFs)
• Review and reconcile clinical trial data against source documents, querying and resolving discrepancies with site staff
• Monitor investigational product accountability, storage, and dispensing at trial sites
• Assess site compliance with the protocol, ICH-GCP, and applicable local regulations
• Identify, document, and escalate protocol deviations, adverse events, and serious adverse events per reporting timelines
• Maintain and review the Trial Master File (TMF) and site regulatory files to ensure inspection readiness
• Build and maintain strong working relationships with investigators, site coordinators, and study staff
• Track site performance metrics, including enrollment progress, query resolution, and data entry timelines
• Prepare timely and accurate monitoring visit reports and follow-up letters
• Support site staff training on protocol requirements, study procedures, and data entry systems
• Assist with audit and regulatory inspection preparation and follow-up at assigned sites

Required Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field
• 1–3+ years of experience as a CRA, clinical trial monitor, or in a clinical research role (entry-level candidates with strong clinical/research backgrounds may be considered for Associate CRA positions)
• Working knowledge of ICH-GCP guidelines and relevant regulatory requirements (FDA, EMA, etc.)
• Familiarity with clinical trial monitoring processes, including SDV/SDR and query management
• Experience with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS)
• Strong attention to detail and analytical skills
• Excellent written and verbal communication skills
• Ability to travel to investigational sites as required

Preferred Qualifications

• CCRA (Certified Clinical Research Associate) or SoCRA/ACRP certification
• Experience monitoring multi-site or global clinical trials
• Therapeutic area experience relevant to clinical pipeline (e.g., oncology, cardiology, CNS) is valuable
• Experience with risk-based monitoring (RBM) approaches

Key Competencies

• Regulatory and compliance awareness
• Organizational skills and time management across multiple sites
• Problem-solving and sound clinical judgment
• Relationship management with site staff and investigators
• Adaptability and independent decision-making in the field

Organizational Expectations

All employees are expected to:

• Uphold the organization's mission, values, and commitment to ethical research.
• Protect the rights, safety, dignity, and confidentiality of research participants.
• Work respectfully with diverse communities, patients, staff, investigators, and external partners.
• Follow all applicable organizational policies, research protocols, regulatory requirements, and compliance standards.
• Maintain accurate documentation and timely communication.
• Participate in training, team meetings, quality improvement activities, and performance review processes.
• Support a culture of accountability, transparency, collaboration, and continuous learning.

Work Environment

This position may require work in a clinical, office, hybrid, or community-based setting. The role may involve interaction with patients, research participants, clinical staff, investigators, sponsors, monitors, and community partners. Some local travel, evening hours, or flexible scheduling may be required depending on study needs.

Equal Employment Opportunity Statement

The organization is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other protected status under applicable law.

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