Kelly Services Clinical Monitoring Coordinator - NIH- Rockville, MD in Rockville, Maryland

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Clinical Monitoring Coordinator to work onsite with the National Institutes of Health in Rockville, MD.

This is a long-term contract position which offers:

    • Competitive salary with comprehensive benefit package
    • Tremendous growth opportunity
    • Opportunity to work at NIH, the world's foremost medical research center
    • Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com

TASKS. The contractor shall:

  • Schedule and conduct site visits, including site evaluation and qualification, initiation, interim, for cause, pharmacy and close out monitoring visits

  • Develop and reviews clinical monitoring plans and audit plans for CTP clinical trials

  • Reviews CTP monitoring and audit reports for ongoing studies, works to resolve monitoring/auditing findings by identifying necessary corrective actions and preventive measures; works with CTP teams to implement corrective actions and preventive measures

  • Review CTP monitoring reports, audit reports, and performance metrics reports in aggregate to identify trends across research sites. Proposes recommendations to CTP leadership to address those trends

  • Track monitoring and audit reports to ensure they are delivered to CTP within the required timeframe and that issues are resolved in an appropriate and timely manner. Communicates and coordinates effectively with internal project staff members, site staff, and other external colleagues

  • Reviews, coordinates, and contributes to protocol documents and required reports, such as study protocol documents and consent forms, SAEs, project and protocol deviation reports, accrual and other study status and/or study website reports

  • Reviews and contributes to the development and/or modification of study and project materials, such as MOPs, CMPs, audit reports, SOPs

  • Attend and participates in meetings with internal and external colleagues. Leads discussions relating to monitoring and auditing

  • Coordinates and conducts trainings for site staff and internal and external colleagues on monitoring/auditing best practices, trend analysis, and similar topics

  • Schedules and completes training in accordance with project needs

REQUIREMENTS. The contractor must have:

  • Master’s degree in Life Sciences or other related discipline. Two (2) years of specialized experience plus a BA/BS degree is equivalent to a Master’s degree.

  • Four (4) years of experience in a related field. Expertise in the fundamentals of clinical trials. Experience in clinical data management, database operations and analysis. Familiarity with IRB requirements.

  • Experience as a Clinical Research Associate (clinical monitor)

  • Ability to travel domestically and internationally approximately 10-20% of the time-

  • Demonstrated understanding of FDA clinical research regulations for a Clinical Research Associate and relevant ICH/GCP guidelines, especially related to clinical monitoring and auditing

  • Skilled in prioritization, problem-solving, organization, critical thinking, decision-making, time management and planning activities

  • Self-motivated and high attention to detail Ability to collaborate with internal and external colleagues and work well in team-oriented setting

  • Excellent oral and written communication; exceptional interpersonal skills

  • Ability to work remotely with a high degree of independence

  • Skilled in project management/computer proficient in Microsoft Office

PLEASE APPLY ONLINE.

Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm