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Job Details


Labcorp (Drug Development)

Clinical Research Associate I, Monitoring Excellence Academy

Pharmaceuticals

All

Full Time

On Site

No

Muskegon, Michigan, United States

Clinical Research Associate I, Monitoring Excellence Academy

United States - Illinois and Michigan

Must Reside Within 60 minutes of a Major HUB Airport; No Smaller Regional Airports

Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks – working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.

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 FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

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

Additional Responsibilities Include:

  • 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

  • Organize and make presentations at Investigator Meetings; participate in the development of protocols and Case Report Forms and clinical trial reports

  • Participate in writing clinical trial reports as assigned

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

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

Requirements:

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)

  • Two or more years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)

  • COVID-19 vaccination required

  • 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

  • Valid Driver's License required

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

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.

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