Senior Clinical Research Associate

The Judge Group; United States; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

Job summary

The Judge Group is seeking a Senior Clinical Research Associate (CRA) to act as the primary site contact and site manager throughout all phases of oncology trials for novel immune therapies. This role drives site relationships, monitors compliance, and supports data integrity and patient safety.

Responsibilities include site visits, regulatory document management, monitoring activities, and collaboration with investigators.

Qualifications

• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• Demonstrated high level of monitoring skill with independent professional judgment
• Demonstrated understanding of medical/therapeutic area knowledge (oncology) and medical terminology
• Knowledge of e-TMF and CTMS set up and maintenance processes

Responsibilities

• Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial
• Conducts site visits including pre-study, initiation, interim monitoring, and close-out visits to ensure protocol and regulatory compliance
• Performs remote and on-site monitoring & oversight activities to ensure data quality and patient safety
• Collects, reviews, and monitors regulatory documents for study start-up, study maintenance, and study close-out
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, data queries, and site performance
• Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per protocol to upper management
• Manages and maintains information in Clinical Trial Management System and eTMF
• Supports site selection activities and audit/inspection readiness
• Coordinates with Clinical Trial Assistant to collect and review regulatory documentation
• Maintains documentation in CTMS and eTMF as appropriate

Skills

Clinical research knowledge

Monitoring skills

Oncology knowledge

eTMF/CTMS knowledge

Education

Bachelor’s degree in science

Tools

CTMS

eTMF

Job description

Senior Clinical Research Associate (CRA) will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites to support ongoing and future oncology clinical trials of novel immune therapies for various cancers.

CLINICAL SITE MONITORING AND MANAGEMENT

• Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial
• Conducts site visits including but not limited to pre-study visits, initiation visits, interim monitoring visits, close-out visits to ensure compliance with protocols, Sponsor SOPs, ICH/GCP and all applicable regulations
• Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate, and unbiased; subjects' rights, safety, and well-being are protected
• Collects, reviews, and monitors required regulatory documents for study start-up, study maintenance, and study close-out
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, missing data and data queries, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance
• Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per protocol to upper management
• Performs investigational product accountability through physical inventory and record review
• Participates & provides inputs on site selection activities
• Supports audit/inspection activities as needed
• Work with in-house Clinical Trial Assistant to collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
• Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• Demonstrated high level of monitoring skill with independent professional judgment.
• Demonstrated understanding of medical/therapeutic area knowledge (oncology) and medical terminology
• Knowledge of e-TMF and CTMS set up and maintenance processes

POSITION REQUIREMENTS

• Bachelor’s degree in science from an accredited institution with strong emphasis in science and/or biology
• Minimum of 3 to 4 years of clinical monitoring and direct site management experience in a bio/pharma company
• Experience monitoring oncology trials is required
• Applicants may be eligible to work remotely depending on location
• Ability to travel domestically approximately 50% to 75% of working time
• Current driver's license preferred

Benefits Featured

Medical, Dental , and Vision Insurance is offered to qualified candidates.