Clinical Research Coordinator 2

Job Title: Clinical Research Coordinator 2

Location: Palo Alto CA 94304

Duration: 6 Months

Number of hours per week: 40

Shift timing/schedule: Fully Onsite Monday through Friday approx. 8-5

Summary

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:

Bachelors 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.

Certifications and Licenses:

• • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
  • Must possess and maintain a valid California non-commercial Class C Drivers License if applicable.

PHYSICAL REQUIREMENTS*:

• • Frequently stand walk twist bend stoop squat and use fine light/fine grasping.
  • Occasionally sit reach above shoulders perform desk based computer tasks use a telephone and write by hand lift carry push and pull objects that weigh up to 40 pounds.
  • Rarely kneel crawl climb ladders grasp forcefully sort and file paperwork or parts rarely lift carry push and pull objects that weigh 40 pounds or more.
  • Ability to drive day or night if applicable.

WORKING CONDITIONS:

• • Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals blood body fluid or tissues and risk of exposure to contagious diseases and infections.
  • May require extended or unusual work hours based on research requirements and business needs.

WORK STANDARDS:

• • When conducting university business must comply with the California Vehicle Code and client driving requirements if applicable.
  • Interpersonal Skills: Demonstrates the ability to work well with colleagues and clients and with external organizations.
  • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.