100% Clinical Trial & Data Management Research Associate - Emergency Medicine
University of Iowa, Iowa City, IA, United States
The Clinical Trial & Data Management Research Associate role in Emergency Medicine (EM) will be an integral member of the research team. This position will provide support for Emergency Medicine working alongside the ICTS team performing activities which are vitally important to grow and foster innovation through research support endeavors. This position will apply clinical skills to administer, deliver, and evaluate research protocols.
Research/Clinical Activities, Subject Recruitment and Enrollment
Screen participant for study eligibility.
Educate participant on scope of study, potential risks and benefits, possible alternatives, and study requirements for participant.
Communicate with principal investigator and verify participant eligibility.
Administer study treatments and identify adverse reactions.
Recruit, enroll and obtain informed consent for clinical research activities. Oversee the recruitment of participants and scheduling of trial-related procedures.
Prepare study recruitment materials. Develop complex study recruitment materials.
Protocol Development/Management and Study Responsibilities
Collaborate with Principal Investigator and the study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
Assess participants for problems related to protocol. Oversee CRF development, database development and maintenance.
Review query reports and resolve all monitoring visit issues.
Perform and monitor randomizations.
Develop complex study materials used in conduction of study.
Communicate with local health care practitioners, agencies, and sponsors as needed.
Data Collection and Monitoring
Participate in the design, development, and testing of clinical research trial data systems.
Maintain communication between health care clinical information systems and research data systems.
Collect and validate data and make recommendations for query resolution.
Assist with identification of data problems and implement change as needed.
Regulatory Guidelines and Documents
Manage and organize regulatory documentation.
Prepare and submit regulatory documents.
Assist sponsor with on-site audits of research and clinical data.
Monitor and maintain compliance with regulatory guidelines and documents.
Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
Carry out corrective action plan for reportable events.
Financial Responsibility
Assist in the development and administer study budgets.
Participate in preparation of grant applications for extramural funding.
Oversee internal pilot funding program application process.
Assist with tracking and reconciling grant budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.
Education Requirements
A Bachelor’s degree in a Health Science field or an equivalent combination of education and research experience.
Experience Requirements
A minimum of one year experience designing, developing, and implementing recruitment program materials.
Working knowledge of Good Clinical Practice (GCP) in research.
Excellent written and verbal communication skills.
Ability to work nights and weekends.
Must be proficient in computer software applications (MS Word, Excel, PowerPoint, and Outlook).
Desired Qualifications
Experience with REDCap, Epic and ACCESS.
Previous experience in data collection and entry.
Experience in processing research regulatory documents and ethics preparation.
Excellent time management skills and ability to perform detail oriented work.
1-3 years of clinical research experience.
Experience developing and working with research budgets/billing.
A current, valid Registered Nurse license or Respiratory Therapist license.
Database management experience including entering, tracking and maintaining data and troubleshooting.
Application Process
In order to be considered, applications must upload a resume. Job openings are posted for a minimum of 7 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. For questions or additional information, please contact Katie McVay at katie-mcvay@uiowa.edu. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.
Additional Information
Classification Title: Clin Trials Rsrch Associate
Appointment Type: Professional and Scientific
Schedule: Full-time
Work Modality Options: On Campus
Compensation
Pay Level: 4A
Contact Information
Organization: Healthcare
Contact Name: Katie McVay
Contact Email: katie-mcvay@uiowa.edu
#J-18808-Ljbffr
Research/Clinical Activities, Subject Recruitment and Enrollment
Screen participant for study eligibility.
Educate participant on scope of study, potential risks and benefits, possible alternatives, and study requirements for participant.
Communicate with principal investigator and verify participant eligibility.
Administer study treatments and identify adverse reactions.
Recruit, enroll and obtain informed consent for clinical research activities. Oversee the recruitment of participants and scheduling of trial-related procedures.
Prepare study recruitment materials. Develop complex study recruitment materials.
Protocol Development/Management and Study Responsibilities
Collaborate with Principal Investigator and the study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
Assess participants for problems related to protocol. Oversee CRF development, database development and maintenance.
Review query reports and resolve all monitoring visit issues.
Perform and monitor randomizations.
Develop complex study materials used in conduction of study.
Communicate with local health care practitioners, agencies, and sponsors as needed.
Data Collection and Monitoring
Participate in the design, development, and testing of clinical research trial data systems.
Maintain communication between health care clinical information systems and research data systems.
Collect and validate data and make recommendations for query resolution.
Assist with identification of data problems and implement change as needed.
Regulatory Guidelines and Documents
Manage and organize regulatory documentation.
Prepare and submit regulatory documents.
Assist sponsor with on-site audits of research and clinical data.
Monitor and maintain compliance with regulatory guidelines and documents.
Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
Carry out corrective action plan for reportable events.
Financial Responsibility
Assist in the development and administer study budgets.
Participate in preparation of grant applications for extramural funding.
Oversee internal pilot funding program application process.
Assist with tracking and reconciling grant budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.
Education Requirements
A Bachelor’s degree in a Health Science field or an equivalent combination of education and research experience.
Experience Requirements
A minimum of one year experience designing, developing, and implementing recruitment program materials.
Working knowledge of Good Clinical Practice (GCP) in research.
Excellent written and verbal communication skills.
Ability to work nights and weekends.
Must be proficient in computer software applications (MS Word, Excel, PowerPoint, and Outlook).
Desired Qualifications
Experience with REDCap, Epic and ACCESS.
Previous experience in data collection and entry.
Experience in processing research regulatory documents and ethics preparation.
Excellent time management skills and ability to perform detail oriented work.
1-3 years of clinical research experience.
Experience developing and working with research budgets/billing.
A current, valid Registered Nurse license or Respiratory Therapist license.
Database management experience including entering, tracking and maintaining data and troubleshooting.
Application Process
In order to be considered, applications must upload a resume. Job openings are posted for a minimum of 7 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. For questions or additional information, please contact Katie McVay at katie-mcvay@uiowa.edu. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.
Additional Information
Classification Title: Clin Trials Rsrch Associate
Appointment Type: Professional and Scientific
Schedule: Full-time
Work Modality Options: On Campus
Compensation
Pay Level: 4A
Contact Information
Organization: Healthcare
Contact Name: Katie McVay
Contact Email: katie-mcvay@uiowa.edu
#J-18808-Ljbffr