Senior Clinical Research Associate

Overview:

Job Summary (Primary function)

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 comply with Good Clinical Practice (GCP), Company SOPs and all applicable regulatory requirements.

The Senior CRA is a seasoned professional with wide-ranging experience and a thorough understanding of GCP and ICH principles. The experienced Senior CRA identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the Senior CRA will establish strong, positive relationships with both internal and external partners. This individual contributes to the determination, development and/or implementation of efficient and effective approaches to study site management.

Essential Functions of the Job (Key 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 Data Management in development, review and/or testing of eCRFs and eCRF Completion Guidelines. Also 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.
• Demonstrates strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Demonstrates an in-depth understanding of study protocols and related procedures.
• Contributes to CRA team knowledge by acting as process and/or system Subject Matter Expert (SME), sharing best practices; developing new process(es), when needed; making recommendations for continuous improvement
• Providing training/coaching/mentoring to other CRAs as needed.
• Assists in developing presentations for internal team and Investigator meetings.

• Assumes responsibility of and independently completes special projects, if assigned, with minimal monitoring management guidance.

• The follow items are only applicable for Ex-Us CRAs:

o In conjunction with study team, supports feasibility and site selection process for clinical studies.

o Prepares EC packages and submissions, notifications to Regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by supervisors.

o Negotiates study budgets with Investigator sites and assists SSU Team with CTA as assigned.

o Supports ADCO in providing CRO oversight for assigned studies

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Position requires BA/BS preferably in the Life Sciences, or RN,
• Minimum of 5+ 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
• Demonstrated high level of monitoring skill with independent professional judgment
• Possess excellent 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
• Strong knowledge of concepts of clinical research and drug development
• Strong working knowledge of EDC, IVRS and CTMS systems
• Proficient in the use of Microsoft Office
• Ability to work highly independently across multiple studies, projects and sites. 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
• Demonstrated ability to mentor/lead
• 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.
• Ex-US: 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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