Clinical Research Coordinator

Job Description

Job Description

Conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

CORE DUTIES:

• • Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
  • Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
  • Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
  • Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
  • Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
  • Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
  • Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
  • Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
  • Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
  • Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.

MINIMUM REQUIREMENTS:

Education & Experience:

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Knowledge, Skills and Abilities:

• • Strong interpersonal skills.
  • Proficiency in Microsoft Office and database applications.
  • Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
  • Knowledge of medical terminology.
  •  
• Requirements:

MINIMUM REQUIREMENTS:

Education & Experience:

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Certifications and Licenses:

• • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.

As a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.\r\rAs a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.