How to Apply
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
Clinical Research Coordinator for the Oncology CTSU – Gold Team
In collaboration with the physician team, the Clinical Research Coordinator will primarily be responsible for study coordination, implementation and evaluation of gynecology oncology clinical trials in order to meet all protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. The Clinical Research Coordinator utilizes effective project management and critical thinking skills to recognize, assist, prevent and/or manage issues within the clinical trial(s) & research studies. The candidate is required to have a working knowledge of protocol requirements, strong interpersonal, organizational and communication skills, and a commitment to continued learning.
- Managing multiple research studies simultaneously assisting O-CTSU Portfolio Manager with the oversight of the GYO portfolio.
- Attends team meetings and weekly tumor board, presenting information (as needed) in organized fashion; possibly attends investigator & scientific meetings
- Manages pre-screening, recruitment, screening, and accrual of patients into internal and external clinical trials.
- Collaborates with the principal investigator in all aspects of a clinical trial & research studies;
- Participates in protocol development with the study team
- Conducts or assists with informed consent discussion with patient and family to outline study purpose, risks and potential benefits; review all trial required procedures and visits; answer questions related to study participation as applicable; and act as a patient/family advocate.
- Provides patient education and develops patient education materials/protocol tools specific to research study to facilitate compliance; Provides staff education on general clinical research information and study specific activities.
- Coordinates study enrollment, protocol treatment, and completion of study requirements for patients participating in clinical studies with pro-active management plans prior to research visits.
- Responsible for collecting and managing all source data elements associated with clinical study implementation, execution and close out. May complete electronic or paper case report forms for patient & laboratory data. Will work closely with study monitors, manage site visits and help with resolving queries.
- May prepare reports for research studies including case report forms, regulatory compliance documentation, and Serious Adverse Event reports; communicates with local, federal or commercial sponsors, as needed.
- Coordinates with O-CTSU Regulatory for IRB processes & safety oversight.
- Coordinates with O-CTSU Finance and Portfolio Manager on monitoring budget for selected aspects of research studies.
- Maintains knowledge of current ICH and FDA guidelines. Facilitates and maintains full regulatory compliance and working knowledge of protocol requirements and good clinical practices as set forth by federal regulations.
- Performs other duties as assigned (perform ECG or other procedures; order study specific labs, provide & receive coverage for other clinical research teams, etc.).
- Bachelor's Degree in biological sciences, health sciences or other relevant field or an equivalent combination of education and experience required.
- 3+ years of experience in coordination of clinical research at an investigator site or academic medical center including coordination of clinical research and/or data collection/management.
- Expertise in research and project management including complex and large-scale research projects and clinical trial protocol feasibility assessments.
- Maintains currents PEERS, CITI or NIH Protection of Human Subjects Training Certification annually.
- Excellent computer skills with proficiency in clinical office software (Microsoft Word, Outlook Excel).
- Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
- Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines.
- Willingness to be flexible in a dynamic working environment.
- Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
- Master's Degree
- Certified Clinical Research Professional - SOCRA/ACRP
- Previous experience with NIH, NCI, or other federal agencies and industry sponsors.
- Training & access to clinical & research systems; Epic EMR, Forte OnCore CTMS, RedCap, Click IRB eResearch, etc.
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks will be performed in compliance with the Fair Credit Reporting Act.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.