Clinical Research Coord Assoc/Technician/ Assistant
4.
3 Full-time 2 hours ago Full Job Description 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.
Summary This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN).
We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding.
Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration.
With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III.
As a team member, we will invest in your education, training, career development and certification.
We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals.
People want MichiganAnswers(TM).
Help discover them.
This Clinical Research Coordinator (CRC) position my provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex.
Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required.
This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work.
It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency.
This position can perform the majority of tasks independently and perform quality checks of their work.
They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention.
Key behavioral competency descriptors include demonstrate, implement, execute, and use.
Why Join Michigan Medicine? Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850.
Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems.
In some way, great or small, every person here helps to advance this world-class institution.
Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to? Excellent medical, dental and vision coverage effective on your very first day 2:
1 Match on retirement savings Responsibilities Characteristic Duties and
Responsibilities:
Independent knowledge, skills, and abilities within all 8 competency domains is expected:
Scientific Concepts and Research Design Ethical Participant Safety Considerations Investigational Products Development and Regulation Clinical Study Operations (GCPs) Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role.
The clinical research coordinator hired for this posting will specialize in Data/Regulatory Float.
Examples of duties a successful candidate in this role will perform:
Clinical Research Coordinator - Associate Demonstrates the ability to document data in accordance with ALCOA-C principles.
Explains how to utilize information from the EMR and study databases.
Completes complex data collection during study visits.
Demonstrates ability to resolve data queries.
Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.
Schedules, assists with preparation for, and attends study initiations meetings, monitor visits, and audits.
Explains and performs study operational activities in compliance with Good Clinical Practice (GCP).
Explains proper documentation techniques as outlined in the ICH-GCP guidelines.
Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.
gov and obtain the NCT.
Demonstrates understanding of University and Federal guidelines in order to assist with Investigator-Initiated studies.
Collaborates with MIAP for INDs and IDEs.
Demonstrates an understanding of the elements of subject safety, related documentation, and reporting.
Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
Demonstrates ability to maintain essential regulatory documents, as outlined in the ICH-GCP guidelines.
Maintenance of updated regulatory documentation.
This position reports directly to a CRC-Lead, CRC-Project Manager, or a unit Administrator, Director.
Clinical Research Coordinator - Technician This position may independently provide study coordination for simple and moderately complex clinical research studies.
As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity.
Mastery of all job duties from the Clinical Research Assistant position is required.
Completes simple to moderately complex CRFs.
Can resolve simple to moderately complex queries (e.
g.
, data error changed numerous values in EDC).
Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
May complete new eResearch applications.
May maintain essential regulatory documents, as outlined in the ICH-GCP guidelines.
Prepares and participates in internal and external audits.
Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
Clinical Research Coordinator - Assistant This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects.
This position may assist with study coordination but will not be assigned clinical trials independently.
This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.
Demonstrates the ability to complete simple data collection during study visits (e.
g.
, basic demographic information).
Enters data to complete forms (CRFs) on paper, databases, or EDCs.
Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs, as assigned.
May administrator minimal risk consents, surveys, and questionnaires.
Checks own work and confirms accuracy.
Demonstrates ability to perform concomitant medications abstraction.
Uses various NCI AE grading scales.
Builds patient research study charts.
Demonstrates ability to resolve simple queries.
Assists in quality control efforts (e.
g.
, review of consents for signatures).
May work with regulatory support to collect essential documents and maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.
).
Assists with AEs and SAEs, ORIOs reporting.
Uses proper documentation techniques, as outlined in the ICH-GCP guidelines.
Required Qualifications Clinical Research Coordinator - Associate Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience Professional certification through ACRP (CCRC) or SOCRA (CCRP) External hires are required to earn certification within 6-month probationary period Minimum of 2
years direct related experience Experience must meet minimal equivalent experience at each prior level within the Michigan Medicine CRC Career Ladder Clinical Research Coordinator - Technician Associate Degree or equivalent in clinical research experience Minimum 1
years direct related experience Clinical Research Coordinator - Assistant High School Diploma Desired Qualifications Clinical Research Coordinator - Associate 4
years of direct related experience Clinical Research Coordinator - Technician Bachelor's Degree; Health Science field preferred or related certification Understanding of medical terminology Experience in a large, complex, healthcare setting Ability to effectively communicate with staff and faculty of all levels Knowledge of University policies and procedures Clinical Research Coordinator - Assistant Bachelor's Degree, Associate Degree, some college; Health Science field preferred or related certification Understanding of medical terminology Experience in a large, complex, healthcare setting Ability to effectively communicate with staff and faculty of all levels Knowledge of University policies and procedures Work Schedule Monday through Friday, core business hours.
Occasionally evening or weekend work to meet deadlines or support patient care.
Underfill Statement This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates' qualifications.
Additional Information Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research.
Our community supports belonging, which are core to the culture and values of the Medical School Office of Research.
Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people Michigan and the world.
We strive to create a work culture where each team member feels respected, valued, and safe.
Background Screening Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third-party administrator to conduct background screenings.
Background screenings are performed in compliance with the Fair Credit Report Act.
Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline Job openings are posted for a minimum of seven calendar days.
The review and selection process may begin as early as the eighth day after posting.
This opening may be removed from posting boards and filled any time after the minimum posting period has ended.
Vaccine Requirements COVID-19 vaccinations are required for all students, faculty and staff working in the following areas:
Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A.
Rackham Institute.
This includes those working remotely and temporary workers.
More information on this new policy is available on the U-M Health Response.
U-M EEO/AA Statement The University of Michigan is an equal opportunity/affirmative action employer.
Job Opening ID 230926 Working Title Clinical Research Coord Assoc/Technician/ Assistant Job Title Clinical Research Coord Assoc Work Location Ann Arbor Campus Ann Arbor, MI Full/Part Time Full-Time Regular/Temporary Regular FLSA Status Nonexempt Organizational Group Medical School Department MM O-CTSU Study Coord Data Posting Begin/End Date 2/22/2023 - 3/08/2023 Career Interest Research.
Estimated Salary: $20 to $28 per hour based on qualifications.
3 Full-time 2 hours ago Full Job Description 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.
Summary This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN).
We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding.
Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration.
With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III.
As a team member, we will invest in your education, training, career development and certification.
We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals.
People want MichiganAnswers(TM).
Help discover them.
This Clinical Research Coordinator (CRC) position my provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex.
Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required.
This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work.
It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency.
This position can perform the majority of tasks independently and perform quality checks of their work.
They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention.
Key behavioral competency descriptors include demonstrate, implement, execute, and use.
Why Join Michigan Medicine? Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850.
Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems.
In some way, great or small, every person here helps to advance this world-class institution.
Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to? Excellent medical, dental and vision coverage effective on your very first day 2:
1 Match on retirement savings Responsibilities Characteristic Duties and
Responsibilities:
Independent knowledge, skills, and abilities within all 8 competency domains is expected:
Scientific Concepts and Research Design Ethical Participant Safety Considerations Investigational Products Development and Regulation Clinical Study Operations (GCPs) Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role.
The clinical research coordinator hired for this posting will specialize in Data/Regulatory Float.
Examples of duties a successful candidate in this role will perform:
Clinical Research Coordinator - Associate Demonstrates the ability to document data in accordance with ALCOA-C principles.
Explains how to utilize information from the EMR and study databases.
Completes complex data collection during study visits.
Demonstrates ability to resolve data queries.
Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.
Schedules, assists with preparation for, and attends study initiations meetings, monitor visits, and audits.
Explains and performs study operational activities in compliance with Good Clinical Practice (GCP).
Explains proper documentation techniques as outlined in the ICH-GCP guidelines.
Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.
gov and obtain the NCT.
Demonstrates understanding of University and Federal guidelines in order to assist with Investigator-Initiated studies.
Collaborates with MIAP for INDs and IDEs.
Demonstrates an understanding of the elements of subject safety, related documentation, and reporting.
Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
Demonstrates ability to maintain essential regulatory documents, as outlined in the ICH-GCP guidelines.
Maintenance of updated regulatory documentation.
This position reports directly to a CRC-Lead, CRC-Project Manager, or a unit Administrator, Director.
Clinical Research Coordinator - Technician This position may independently provide study coordination for simple and moderately complex clinical research studies.
As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity.
Mastery of all job duties from the Clinical Research Assistant position is required.
Completes simple to moderately complex CRFs.
Can resolve simple to moderately complex queries (e.
g.
, data error changed numerous values in EDC).
Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
May complete new eResearch applications.
May maintain essential regulatory documents, as outlined in the ICH-GCP guidelines.
Prepares and participates in internal and external audits.
Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
Clinical Research Coordinator - Assistant This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects.
This position may assist with study coordination but will not be assigned clinical trials independently.
This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.
Demonstrates the ability to complete simple data collection during study visits (e.
g.
, basic demographic information).
Enters data to complete forms (CRFs) on paper, databases, or EDCs.
Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs, as assigned.
May administrator minimal risk consents, surveys, and questionnaires.
Checks own work and confirms accuracy.
Demonstrates ability to perform concomitant medications abstraction.
Uses various NCI AE grading scales.
Builds patient research study charts.
Demonstrates ability to resolve simple queries.
Assists in quality control efforts (e.
g.
, review of consents for signatures).
May work with regulatory support to collect essential documents and maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.
).
Assists with AEs and SAEs, ORIOs reporting.
Uses proper documentation techniques, as outlined in the ICH-GCP guidelines.
Required Qualifications Clinical Research Coordinator - Associate Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience Professional certification through ACRP (CCRC) or SOCRA (CCRP) External hires are required to earn certification within 6-month probationary period Minimum of 2
years direct related experience Experience must meet minimal equivalent experience at each prior level within the Michigan Medicine CRC Career Ladder Clinical Research Coordinator - Technician Associate Degree or equivalent in clinical research experience Minimum 1
years direct related experience Clinical Research Coordinator - Assistant High School Diploma Desired Qualifications Clinical Research Coordinator - Associate 4
years of direct related experience Clinical Research Coordinator - Technician Bachelor's Degree; Health Science field preferred or related certification Understanding of medical terminology Experience in a large, complex, healthcare setting Ability to effectively communicate with staff and faculty of all levels Knowledge of University policies and procedures Clinical Research Coordinator - Assistant Bachelor's Degree, Associate Degree, some college; Health Science field preferred or related certification Understanding of medical terminology Experience in a large, complex, healthcare setting Ability to effectively communicate with staff and faculty of all levels Knowledge of University policies and procedures Work Schedule Monday through Friday, core business hours.
Occasionally evening or weekend work to meet deadlines or support patient care.
Underfill Statement This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates' qualifications.
Additional Information Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research.
Our community supports belonging, which are core to the culture and values of the Medical School Office of Research.
Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people Michigan and the world.
We strive to create a work culture where each team member feels respected, valued, and safe.
Background Screening Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third-party administrator to conduct background screenings.
Background screenings are performed in compliance with the Fair Credit Report Act.
Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline Job openings are posted for a minimum of seven calendar days.
The review and selection process may begin as early as the eighth day after posting.
This opening may be removed from posting boards and filled any time after the minimum posting period has ended.
Vaccine Requirements COVID-19 vaccinations are required for all students, faculty and staff working in the following areas:
Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A.
Rackham Institute.
This includes those working remotely and temporary workers.
More information on this new policy is available on the U-M Health Response.
U-M EEO/AA Statement The University of Michigan is an equal opportunity/affirmative action employer.
Job Opening ID 230926 Working Title Clinical Research Coord Assoc/Technician/ Assistant Job Title Clinical Research Coord Assoc Work Location Ann Arbor Campus Ann Arbor, MI Full/Part Time Full-Time Regular/Temporary Regular FLSA Status Nonexempt Organizational Group Medical School Department MM O-CTSU Study Coord Data Posting Begin/End Date 2/22/2023 - 3/08/2023 Career Interest Research.
Estimated Salary: $20 to $28 per hour based on qualifications.
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