Clinical Research Associate (m/f/d)

The primary responsibilities of this position include assessing qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies.

This individual will ensure that clinical trials are conducted according to the approved protocol/protocol amendments and complies with Good Clinical Practice (GCP), Company SOPs and all applicable regulatory requirements.

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.
• In conjunction with study team, supports feasibility and site selection process for clinical studies.
• Prepares EC packages and submissions, notifications to Regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by supervisors.
• Negotiates study budgets with Investigator sites and assists SSU Team with CTA as assigned.
• Supports ADCO in providing CRO oversight for assigned studies

Requirements

• 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.
• Proficient in speaking and writing English and the country language when applicable.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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