- Adhere to local and federal policies for conducting research and documentation of study activities.
- Recruit interested individuals to participate in research projects in accordance with the IRB approved protocol processes and study documents.
- Engage with the research team in verifying subject eligibility, facilitating subject enrollments, and ensuring compliant completion of research activities.
- Schedule appointments with participants and assessment staff per protocols. Provide participants with instructions and materials needed to prepare for the visit. Remind participants of upcoming visits using approved communication methods.
- Prepare for study appointments per protocol by: reserving rooms and equipment; printing off forms; creating participant profiles within data capture systems; charging equipment; and other tasks as needed.
- Obtain informed consent and assent, including assessments of capacity to consent to research. Re-consent participants as needed after protocol modifications.
- Communicate with principal investigator/study team to ensure study specific procedures are completed.
- Collect data and conduct assessments as part of study specific visits, in-person or remotely, as needed per protocol specific guidelines, including data abstraction from medical records using standard forms.
- Assist with other documentation as directed such as procure outside medical records or documenting participant study-related visits in medical chart.
- Support timely and quality data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data including lab/imaging results; maintenance of subject research charts.
- Complete required forms for any adverse events, serious or otherwise, and report and notify appropriate individuals/entities per research requirements.
- Use University systems such as Florence, OnCore, Box, and REDCap to maintain information for all necessary research documentation.
- Assist in ordering and management of study supplies, as needed.
- Provide information to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
- Effectively work independently in multiple locations with hospital and clinic staff to complete research related tasks
- Support the completion of required regulatory documentation and other regulatory tasks as needed
- In collaboration with the research team, interpret study protocols and inform the development of consent forms and other materials needed for each clinical research study
- Coordinate with Regulatory Specialists or Project Managers for submission of modifications to IRB for review. Support responses to clarification questions or stipulations from the IRB, as required.
- Implement updates to materials after protocol modifications are approved (e.g., update consent forms to the approved version)
- Maintain regulatory documents, such as: enrollment logs; participant visit logs; protocol deviation logs; personnel training records
- Administrative responsibilities such as communication coordination.
- BA/BS or a combination of related education and work to equal 4 years of experience in a clinical or research setting in related field.
- Computer proficiency and ability to navigate multiple software applications (Microsoft Word, Excel and REDCap)
- Demonstrated ability to maintain deadlines and prioritize assignments
- Excellent written, verbal and interpersonal communication skills
- Knowledge of clinical research compliance standards, e.g. informed consent process, adverse event reporting, the Federal Code of Regulations and Good Clinical Practices (GCP) Standards
- Demonstrated data management skills, such as data collection, data entry and quality control
- Detail-oriented with strong organizational, planning and problem-solving skills
- Competitive wages, paid holidays, and generous time off
- Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
- Low-cost medical, dental, and pharmacy plans
- Healthcare and dependent care flexible spending accounts
- University HSA contributions
- Disability and employer-paid life insurance
- Employee wellbeing program
- Excellent retirement plans with employer contribution
- Public Service Loan Forgiveness (PSLF) opportunity
- Financial counseling services
- Employee Assistance Program with eight sessions of counseling at no cost
- Employee Transit Pass with free or reduced rates in the Twin Cities metro area
clinical research coordinator 1- paccs - Minneapolis, MN, United States - University of Minnesota
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Description
About the Job
The primary purpose of this position is to support University faculty performing clinical research in the understanding and treatment of diseases in Pulmonary, Critical Care, Allergy, and Sleep Medicine.
This position reports to the Research Manager, but is accountable to the physician-investigators, program leaders, and members of the clinical research team.
The Clinical Research Coordinator fulfills a dynamic and integral role as a key player in the research team.RESPONSIBILITIES/DUTIES
Protocol/Participant Management (80%)
All required qualifications must be included in the application materials
Required qualifications:
Preferred Qualifications:
Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect.
The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities.
Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.
BenefitsWorking at the University
At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning.
We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.
The University also offers a comprehensive benefits package that includes:How To Apply
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions.
You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.
Additional documents may be attached after application by accessing your My Job Applications page and uploading documents in the My Cover Letters and Attachments section.
Diversity
The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission.
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression.
To learn more about diversity at the U:
Employment Requirements
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.
About the U of M
The University of Minnesota, Twin Cities (UMTC)
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research.
Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St.
Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).