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Clinical Research Coordinator - IM Community Epi

  • Job
    Full-time
    Mid & Senior Level
  • Research & Development
    Healthcare
  • Chicago

AI generated summary

  • You need a bachelor's degree and 4 years of clinical research experience (or 8 years total), coordinating Human Subjects research, knowledge of regulations, and strong project management skills.
  • You will coordinate study activities, manage recruitment and data entry, ensure compliance, oversee audits, report issues, and support training for staff.

Requirements

  • Required Job Qualifications:
  • * Bachelor's degree and 4 years of clinical research experience OR 8 years of clinical research experience.
  • * 3 years coordinating Human Subjects research.
  • * Demonstrate advanced knowledge of Good Clinical Practices and Good Documentation Practices.
  • * Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research.
  • * Strong project management skills including ability to meet deadlines and help coordinate multiple aspects of the ongoing project.
  • * Demonstrated problem-solving, critical decision makings and professional judgement.
  • * Strong analytical and organizational skills with a high attention to details.
  • * Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants and vendors.
  • * Strong verbal and written communication with ability to communicate complex concepts to multiple audiences.
  • * Demonstrated ability to collaborate within multi-disciplinary team settings.
  • * Availability to work evenings, overnight and weekends if called for under the study protocols.
  • * Travel may be required.
  • Preferred Job Qualifications:
  • * Bachelor's degree in Sciences or health-related discipline.
  • * Relevant certification strongly preferred (Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP).

Responsibilities

  • Coordinates all aspects of the study including recruitment, consent, screening, scheduling, tracking and provides study updates to study participants throughout the conduct of the study.
  • May collect and enter data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
  • Submits or partners with a regulatory coordinator to submit study related documents, study protocols and study protocol amendments to the IRB per policy and procedure.
  • Ensures procedural documentation is accurate, complete, and in compliance with institutional, local, state and federal guidelines and regulations related to clinical research.
  • May collect, process and ship potentially biohazardous specimens.
  • May administer more complex structured tests and questionnaires according to research study protocols. May utilize study-related technology and equipment as part of assessment procedures.
  • Provide ongoing study status updates, responds to questions and may create summary report(s) for distribution to PI, Administrator, Office of Research Affairs, Sponsor and Compliance throughout the conduct of the study.
  • Organize and participate in auditing and monitoring visits.
  • Report unanticipated problems (protocol deviations, adverse events, and serious adverse events).
  • Partner with PI(s), sponsor, compliance, clinical staff and manager to identify and improve more complex processes as it relates to the conduct of the research study.
  • May provide oversight, training and coaching to less experienced staff.

FAQs

What is the job title for this position?

The job title is Clinical Research Coordinator - IM Community Epi.

Where is this position located?

This position is located in Chicago, IL at Rush University Medical Center.

What type of work schedule does this position offer?

This position offers a full-time schedule with 8-hour shifts from 8:00 AM to 4:00 PM.

What are the required qualifications for this job?

The required qualifications include a Bachelor's degree and 4 years of clinical research experience or 8 years of clinical research experience, with 3 years coordinating Human Subjects research.

Is experience in Human Subjects research necessary?

Yes, 3 years of coordinating Human Subjects research is necessary.

What knowledge is essential for this role?

Advanced knowledge of Good Clinical Practices (GCP) and current NIH and/or FDA regulations and guidelines related to clinical research is essential.

Are there preferred qualifications for this position?

Yes, a Bachelor's degree in Sciences or a health-related discipline and relevant certification (such as CCRP, CCRA, CCRC, or CIP) are strongly preferred.

Will I need to provide updates to study participants?

Yes, you will be responsible for providing ongoing study status updates and communicating with study participants throughout the conduct of the study.

Will there be opportunities for training and oversight of staff?

Yes, you may provide oversight, training, and coaching to less experienced staff.

Is travel required for this position?

Yes, travel may be required as part of the job responsibilities.

Is there flexibility in working hours?

Yes, availability to work evenings, overnight, and weekends may be required if called for under the study protocols.

Does Rush University Medical Center promote diversity and equal opportunity?

Yes, Rush is an equal opportunity employer and evaluates qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

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