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Senior Clinical Research Associate I, FSP

USA - West Coast Onoclogy

Oncology

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com

Why settle for one thing when you can have everything?

Why settle for one thing when you can have everything?  Labcorp Drug Development gives you the best opportunity for career growth. Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research.

Our reach is global – extending to 60+ countries making us one of the largest CROs. So no matter where you are located on the globe, we have an opportunity for you!

We are seeking a Senior Clinical Research Associate I to be responsible for all aspects of study site monitoring and management including routine monitoring and close-out of clinical sites; maintain study files; conduct pre-study and initiation visits; liaise with vendors; and other duties, as assigned.

Additional Responsibilities include:

• Organize and make presentations at Investigator Meetings

• Participate in the development of protocols and Case Report Forms and clinical trial reports as assigned

• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

• Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

• Travel, including air travel, may be required and is an essential function of the job; prepare accurate and timely trip reports; review progress of projects and initiate appropriate actions to achieve target objectives

• Conduct, report, and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested

Requirements:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate

• Minimum of at least 2 years of onsite Clinical Monitoring experience

• Advanced site monitoring; study site management; and registry administration skills

• Ability to train and supervise junior staff; resolve project related processes

• Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements

• Thorough knowledge of monitoring procedures; Basic understanding of the drug accountability process

• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

• Good planning, organization and problem-solving abilities; Ability to work with minimal supervision

• COVID-19 vaccination required

• Valid Driver's License

Preferred Experience:

• At least 1 year of additional experience in a related field is preferred

Great Benefits at Labcorp:

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:

• Medical

• Dental

• Vision

• Life, STD/LTD

• 401(K)

• ESPP

• Paid time off (PTO) or Flexible time off (FTO)

• Company bonus where applicable

Pay Range: 95-135K

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here (https://cdn.phenompeople.com/CareerConnectResources/COVAGLOBAL/documents/Labcorp-Benefits-TheWayWeLive-1659629596356.pdf) .

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .