Clinical Research Associate II

Job Description:

Job Title: Clinical Research Associate II (CRA II)

Job Location: United States - Remote

Job Overview:

The Clinical Research Associate II (CRA II) is responsible for monitoring assigned investigational sites throughout the clinical trial lifecycle. The CRA II serves as the primary contact for assigned sites and works closely with internal and external study teams to ensure subject safety, data quality, regulatory compliance, and successful study delivery.

Job Duties and Responsibilities:
• Serves as the primary contact for assigned investigational sites and develops effective working relationships with investigators and site staff.
• Schedules and independently conducts monitoring activities, both on-site and remotely, including pre-study/site qualification, site initiation, interim monitoring, and close-out visits, in accordance with study protocols, Monitoring Plans, Company and/or client SOPs, GCP/ICH guidelines, and applicable regulations.
• Ensures the rights, safety, and well-being of clinical trial subjects are protected, including verification of informed consent and subject eligibility.
• Performs source data verification and reviews clinical data for accuracy, completeness, and appropriate documentation; facilitates timely resolution of data queries.
• Reviews site regulatory files and ensures required essential documentation is complete and maintained throughout the study lifecycle.
• Performs Investigational Product accountability and verifies appropriate storage, inventory, dispensing, return/destruction, and related documentation.
• Reviews and supports appropriate reporting and tracking of adverse events and serious adverse events in accordance with regulatory requirements and the Monitoring Plan.
• Manages assigned sites throughout trial conduct, identifies and resolves site-related issues, and appropriately escalates protocol, SOP, GCP, quality, or compliance concerns.
• Prepares high-quality monitoring reports and required site correspondence within established timelines.
• Participates in study meetings, training, investigator meetings, audits, and other project activities as required.
• May support site and study feasibility assessments, IRB/IEC and regulatory submissions, development of monitoring tools and study documentation, and other study-specific activities.
• Works collaboratively with Project and Clinical Operations teams to meet project timelines, quality expectations, and study objectives while maintaining confidentiality and compliance with the Company Quality Management System.

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education and Professional Qualifications
• Four-year college degree, preferably in healthcare, life sciences, or a related field.
• In lieu of a degree, candidates with two or more years of relevant clinical research experience within the pharmaceutical or CRO industries will be considered.

Experience
• Minimum of one year of experience in on-site monitoring of clinical studies.
• Demonstrated ability to independently conduct all types of site monitoring visits.

Skills/Competencies
• Strong written and verbal communication skills.
• Strong interpersonal skills with the ability to build and maintain effective relationships with investigators, site staff, and study team members.
• Strong clinical monitoring and documentation skills, with the ability to independently conduct site monitoring visits.
• Comprehensive knowledge of GCP/ICH guidelines and proficiency in medical terminology.
• Proficient computer skills, including Microsoft Office.
• Strong attention to detail, problem-solving, time management, and organizational skills.
• Ability to exercise sound judgment, work independently, and effectively manage priorities in a matrix environment.

Capabilities
• Ability to travel up to 35%.
• Ability to drive an automobile and maintain a valid driver's license, where applicable.

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