Senior Clinical Research Associate

ICON Strategic Solutions; New York (NY); On-site; USD 67,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Clinical Research Associate, where your expertise in oncology monitoring will play a crucial role in advancing clinical trials. This exciting position offers the opportunity to evaluate and monitor clinical study sites, ensuring compliance with regulatory standards and protocols. You'll develop patient recruitment strategies and maintain strong relationships with site personnel, all while contributing to groundbreaking research in the pharmaceutical industry. With a focus on well-being and work-life balance, this role provides a competitive salary and a range of benefits designed to support you and your family. If you're passionate about making a difference in clinical research, this is the perfect opportunity for you.

Benefits

Health Insurance

401(k)

Life Assurance

Flexible Benefits

Employee Assistance Program

Qualifications

• 2+ years of experience as a Clinical Research Associate.
• Strong understanding of ICH guidelines and GCP.

Responsibilities

• Evaluate and monitor clinical study sites for compliance.
• Train site personnel on study protocols and procedures.

Skills

Oncology Monitoring

Clinical Research

Project Management

Data Analysis

GCP Guidelines

Communication Skills

Education

Bachelor's Degree in Life Sciences

Registered Nurse (RN)

Tools

EDC Systems

IVRS

CTMS

Microsoft Office

Job description

2 weeks ago Be among the first 25 applicants

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Corporate Recruiter at ICON Strategic Solutions - Hiring CRAs / Embedded Model

ICON Strategic Solutions is currently hiring Clinical Research Associates (FSP).

*Must be located in the North East, United States with prior oncology monitoring experience at a CRO or Pharmaceutical.

What you will be doing:

• 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.

You are:

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

Minimum of 2+ (CRA II), 4+ (Sr. CRA) 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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

• 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Customer Service, Research, and Science

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

401(k)

Vision insurance

Medical insurance

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