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Company

ICON Strategic Solutions · 6 hours ago

CRA II - Central

United States

Full-time

Remote

Entry, Mid Level

2+ years exp

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Pharmaceutical Manufacturing

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Responsibilities

Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.

Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements.

Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.

Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.

Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.

Ensures subjects’ rights, safety and well-being are protected.

Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.

Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.

Assists and supports data validation and data cleaning procedures to ensure timelines are met.

Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations.

Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).

Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.

Ensures availability of non-clinical materials for sites.

Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

Gains an in-depth understanding of study protocols and related procedures.

Qualification

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Oncology experienceClinical Research AssociateICH guidelinesClinical Practices (GCP)EDC systemsIVRS systemsCTMS systemsMicrosoft OfficeProject management

Required

Position requires BA/BS, preferably in the Life Sciences, or RN

Minimum of 2+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock

Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials

Possess good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements

Good knowledge of concepts of clinical research and drug development

Strong working knowledge of EDC, IVRS and CTMS systems

Proficiency in the use of the Microsoft Office

Ability to handle and prioritize multiple studies and projects

Ability to work effectively in a team/matrix environment

Ability to understand technical, scientific and medical information

Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills

Works with high quality and compliance mindset

Possess a valid driver’s license

Must be willing to travel and spend 8-10 days /month on site

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs

Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others