Clinical Study Lead

Kelly Services has a one-year contract assignment for a Clinical Study Lead based in Deerfield, IL.  The Clinical Study Lead collaborates with the Study Manager to monitors progress of clinical studies at the site level to verify that the rights and wellbeing of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. The CSL provides support in startup, enrollment, follow up and closure of clinical trial activities. 

Responsibilities: 

  • Communications: Work with study manager to ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence. 
  • Site Compliance: Work with Study manager to ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required. 
  • Event Reporting: Support Study Manager in ensuring that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations (when required) 
  • Collaboration: participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout all study phases. 
    Primary medical affairs contact with study sites. Support/coordinate response to research site supply needs. 
  • Documentation: Manages study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations. 
    Prior to patient enrollment, perform/support review and assessment of study protocol, CRF, other study documents, and data collection processes. 
    Support/coordinate publication process for abstracts and articles 
  • Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Integrity in the work that they do and produce a high quality of work. 
     

Minimum Requirements: 

  • PhD/MD/RN with demonstrated clinical research experience. 
  • Demonstrated knowledge of clinical research and development processes and ability to gain command of process details 
  • Demonstrated knowledge of global and local regulatory requirements 
  • Demonstrated understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.) 
  • Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
  • Demonstrated ability to participate and support sponsor regulatory interactions/inspections 
  • Demonstrated knowledge of the processes around protocol design and feasibility assessment 
  • Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery 
  • Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial 
  • Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation 
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization 
  • Availability to travel (15-20%) within region and/or globally as required 

 

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

 

Perks of being a Kelly employee:

  • Weekly electronic pay
  • Access to more than 3,000 online training courses though Kelly Learning center
  • Group rate insurance options available immediate upon hire*
  • Service bonus plan and holiday pay*
  • Online application system
  • Never an applicant fee

 

*perks to be received upon meeting eligibility requirements

 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 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.

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