Clinical Research Coordinator Lead
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.
SummaryThe Department of Obstetrics and Gynecology seeks an experienced Clinical Research Professional to manage and assist with several gynecology research studies and help grow the GYN Chronic Pain Program.
The ideal candidate will have previous research experience in women's health, project management, recruitment, and will serve as a resource and contact person for multiple active research protocols, research sites and staff.
In addition to administrative dues, the candidate will engage with patients seen within UofM OBGYN and the community for recruitment, enrollment, specimen, and data collection in studies; capture data from medical records and enter into various data systems; communicate with patients regarding study purpose, study activities, and research appointments; create documents for accurate tracking and support faculty and fellows in the Division of Gynecology.
This position requires a flexible schedule, with some evening coverage.
CRC STATEMENT:
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity.
Coordinator experience and mastery of all job duties from the CRC-Lead position on the Michigan Medicine CRC Career Ladder is required.
This position should begin to serve on various clinical research committees at the University level.
This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities.
This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies.
This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work.
This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development.
Key behavioral competency descriptors include:
Design, demonstrate, develop, guide, and support.
Mission StatementMichigan 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.
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 30,000employees 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 Expert level 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 Specific duties will include:
Project Management and Administrative Responsibilities Establishes operational objectives and assignments, and defines and manages project resource needs including project staff.
Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolved Manage a portfolio of multi-site clinical research, when the University of Michigan is the lead center Supports and runs weekly and monthly research meetings Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy Develops standard operating procedures, work-aids and other guidance Creates protocols for specimen collection, processing, shipping, etc.
, and implements procedures to maintain accuracy and efficiency Continually review and evaluate progress of projects and studies in order to identify problems, improve quality and implement solutions or improvements Collaborate with PIs, and liaison to Clinical Trial Service Units, on strategic project resource planning including assisting with staff and study need Work within CTSU framework for initiating and oversight of multiple studies with billing calendars Assist with writing timely reports for funding agencies Assist with preparation of power point slides and visual abstracts of research studies related data Trains and supports study team members Recruit and train appropriate personnel for clinical research Provide supervision of students and temporary employees Work with administrative units to procure supplies for projects Assist PIs and study team members on various duties related to gynecology research as need Provide coordination for multiple clinical research studies of various complexity Ensure clinical research projects completed within specifications Coordinate research efforts with multiple principal investigators, research staff, clinical schedules, and research subjects.
Communicate with IDS (Research Pharmacy) to order investigational drugs and make sure all protocol supplies are on stock.
Collaborates with medical staff to facilitate and optimize the care of research patients Develop and monitor protocols and infrastructure for clinical studies Track, document and report on study progress Investigate, modify, and integrate new procedures as needed Serve as primary liaison between study staff, subjects, investigators, other departments, and sponsors.
Clinical Coordination Responsibilities Review real time medical records to match potential research participants with inclusion/exclusion criteria for active studies Assist with development and implementation of recruitment strategies targeted diverse participants within and outside of Michigan Medicine (including community-based recruitment) Travel to various local sites for screening and recruitment Approach women in person or on the phone, giving study overview, while being sensitive to environment and patients involved.
Explain study thoroughly, review informed consent document, answer questions, and obtain consent Schedule subject visits, follow up interactions as well as coordinating with PI schedules Coordinate subject incentive payment submissions and tracking Maintain accurate and complete documents including, but not limited to:
source documentation, study drug dispense/return logs, subject logs, and all study-related communications.
Request and collect specimens, as well as properly prepare and ship specimens to outside institutions according to study protocol requirements.
Attain in-depth understanding of several study protocols and objectives to assist with successful implementation of all study procedures Run and oversee specialized research devices and equipment Data Related Create documents and databases for screening and recruitment Complete subject documentation and follow up in online system Responsible for data abstraction, entry, management, cleaning and database creation for several studies Triage complex data concerns, create reports on the completeness and quality of the collected data Various data related duties as needed Regulatory & Study reporting Assist Regulatory specialist in preparing and maintaining, IRB (eResearch) applications including new applications, scheduled continuing reviews, amendments, adverse event reporting (events that either occurs in UM research subjects or subjects from other centers in multi-site studies) and other reportable information and occurrences.
Facilitates monitoring or DSMB meetings Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits Working with Research Pharmacy, study medication and chain of custody Attend and participate in meetings with study team to discuss subject enrollment and issues as well as study progress.
Participate in protocol initiation and monitoring visits by study sponsors.
Assist PI with identifying and grading adverse events.
Ensure compliance with GCP, ICH, GOG and FDA regulations, standards and guidelines.
Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations Coordinate and facilitate any regulatory and institutional monitoring visits Training Provides training and mentorship of other clinical research staff on a range of communication and teamwork best practices; maintains certification) Completes Michigan Medicine training for Managing Successfully and Leading Successfully.
Attends and participates in all training assigned to this level.
Supervision Received:
This position reports directly to the Department Senior Research Manager and Director of the Endometriosis and Pelvic Pain Research Group.
Supervision Exercised:
Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder.
Certification is required through Association of Clinical Research Professionals ( ACRP ) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association ( SOCRA ) as a Certified Clinical Research Professionals (CCRP) or equivalent.
Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc.
within six months of date of hire.
(Please review eligibility criteria from SoCRA or ACRP prior to applying.
) Demonstrate ability to work successfully while meeting competing deadlines Excellent interpersonal skills Demonstrated ability to prioritize and exercise good judgement Attention to detail and accuracy Primary activities are performed independently, and decisions are made free from immediate direction.
Excellent communication skills, with the ability to receive and convey information clearly and concisely for various mediums.
Excellent interpersonal and organizational skills, and the ability to work effectively with diverse groups A high degree of initiative and resourcefulness Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills Demonstrates the ability to create and manage databases.
Demonstrated ability to work well under time constraints and meet deadlines Demonstrated coordination, time management and communication skills Capable of conducting all start-up, active implementation, and closeout activities.
Level
Specific Requirements:
LEAD:
CRC Governance Committee review and approval Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
Minimum 5
years of directly related experience in clinical research and clinical trials is necessary Desired Qualifications 6
years of direct related experience Experience with the OnCore clinical trial management system (CTMS) Previous experience with MiChart, RedCap, and Qualtrics Work ScheduleMonday-Friday; hours vary depending on the study needs; general hours are within the 7am-6pm range.
Some evening (5pm-9pm) hours may be required depending on the study needs.
Work Locations Primary location is at the main medical campus in University Hospital South (UH South); with regular work activities at VonVoigtlander Women's Hospital.
This position may include some travel to Michigan Medicine clinical sites such as East Ann Arbor, Brighton, Chelsea, etc.
Some remote work may be allowed depending on study needs.
Additional InformationThe use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.
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 recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world.
We strive to create a work culture where each team member feels respected, valued, and safe.
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 DeadlineJob openings are posted for a minimum of seven calendar days.
The review and selection process maybegin as early as the eighth day after posting.
Thisopening 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.
#J-18808-Ljbffr Recommended Skills Administration Analytical Attention To Detail Auditing Billing Clinical Research Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
SummaryThe Department of Obstetrics and Gynecology seeks an experienced Clinical Research Professional to manage and assist with several gynecology research studies and help grow the GYN Chronic Pain Program.
The ideal candidate will have previous research experience in women's health, project management, recruitment, and will serve as a resource and contact person for multiple active research protocols, research sites and staff.
In addition to administrative dues, the candidate will engage with patients seen within UofM OBGYN and the community for recruitment, enrollment, specimen, and data collection in studies; capture data from medical records and enter into various data systems; communicate with patients regarding study purpose, study activities, and research appointments; create documents for accurate tracking and support faculty and fellows in the Division of Gynecology.
This position requires a flexible schedule, with some evening coverage.
CRC STATEMENT:
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity.
Coordinator experience and mastery of all job duties from the CRC-Lead position on the Michigan Medicine CRC Career Ladder is required.
This position should begin to serve on various clinical research committees at the University level.
This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities.
This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies.
This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work.
This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development.
Key behavioral competency descriptors include:
Design, demonstrate, develop, guide, and support.
Mission StatementMichigan 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.
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 30,000employees 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 Expert level 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 Specific duties will include:
Project Management and Administrative Responsibilities Establishes operational objectives and assignments, and defines and manages project resource needs including project staff.
Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolved Manage a portfolio of multi-site clinical research, when the University of Michigan is the lead center Supports and runs weekly and monthly research meetings Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy Develops standard operating procedures, work-aids and other guidance Creates protocols for specimen collection, processing, shipping, etc.
, and implements procedures to maintain accuracy and efficiency Continually review and evaluate progress of projects and studies in order to identify problems, improve quality and implement solutions or improvements Collaborate with PIs, and liaison to Clinical Trial Service Units, on strategic project resource planning including assisting with staff and study need Work within CTSU framework for initiating and oversight of multiple studies with billing calendars Assist with writing timely reports for funding agencies Assist with preparation of power point slides and visual abstracts of research studies related data Trains and supports study team members Recruit and train appropriate personnel for clinical research Provide supervision of students and temporary employees Work with administrative units to procure supplies for projects Assist PIs and study team members on various duties related to gynecology research as need Provide coordination for multiple clinical research studies of various complexity Ensure clinical research projects completed within specifications Coordinate research efforts with multiple principal investigators, research staff, clinical schedules, and research subjects.
Communicate with IDS (Research Pharmacy) to order investigational drugs and make sure all protocol supplies are on stock.
Collaborates with medical staff to facilitate and optimize the care of research patients Develop and monitor protocols and infrastructure for clinical studies Track, document and report on study progress Investigate, modify, and integrate new procedures as needed Serve as primary liaison between study staff, subjects, investigators, other departments, and sponsors.
Clinical Coordination Responsibilities Review real time medical records to match potential research participants with inclusion/exclusion criteria for active studies Assist with development and implementation of recruitment strategies targeted diverse participants within and outside of Michigan Medicine (including community-based recruitment) Travel to various local sites for screening and recruitment Approach women in person or on the phone, giving study overview, while being sensitive to environment and patients involved.
Explain study thoroughly, review informed consent document, answer questions, and obtain consent Schedule subject visits, follow up interactions as well as coordinating with PI schedules Coordinate subject incentive payment submissions and tracking Maintain accurate and complete documents including, but not limited to:
source documentation, study drug dispense/return logs, subject logs, and all study-related communications.
Request and collect specimens, as well as properly prepare and ship specimens to outside institutions according to study protocol requirements.
Attain in-depth understanding of several study protocols and objectives to assist with successful implementation of all study procedures Run and oversee specialized research devices and equipment Data Related Create documents and databases for screening and recruitment Complete subject documentation and follow up in online system Responsible for data abstraction, entry, management, cleaning and database creation for several studies Triage complex data concerns, create reports on the completeness and quality of the collected data Various data related duties as needed Regulatory & Study reporting Assist Regulatory specialist in preparing and maintaining, IRB (eResearch) applications including new applications, scheduled continuing reviews, amendments, adverse event reporting (events that either occurs in UM research subjects or subjects from other centers in multi-site studies) and other reportable information and occurrences.
Facilitates monitoring or DSMB meetings Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits Working with Research Pharmacy, study medication and chain of custody Attend and participate in meetings with study team to discuss subject enrollment and issues as well as study progress.
Participate in protocol initiation and monitoring visits by study sponsors.
Assist PI with identifying and grading adverse events.
Ensure compliance with GCP, ICH, GOG and FDA regulations, standards and guidelines.
Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations Coordinate and facilitate any regulatory and institutional monitoring visits Training Provides training and mentorship of other clinical research staff on a range of communication and teamwork best practices; maintains certification) Completes Michigan Medicine training for Managing Successfully and Leading Successfully.
Attends and participates in all training assigned to this level.
Supervision Received:
This position reports directly to the Department Senior Research Manager and Director of the Endometriosis and Pelvic Pain Research Group.
Supervision Exercised:
Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder.
Certification is required through Association of Clinical Research Professionals ( ACRP ) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association ( SOCRA ) as a Certified Clinical Research Professionals (CCRP) or equivalent.
Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc.
within six months of date of hire.
(Please review eligibility criteria from SoCRA or ACRP prior to applying.
) Demonstrate ability to work successfully while meeting competing deadlines Excellent interpersonal skills Demonstrated ability to prioritize and exercise good judgement Attention to detail and accuracy Primary activities are performed independently, and decisions are made free from immediate direction.
Excellent communication skills, with the ability to receive and convey information clearly and concisely for various mediums.
Excellent interpersonal and organizational skills, and the ability to work effectively with diverse groups A high degree of initiative and resourcefulness Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills Demonstrates the ability to create and manage databases.
Demonstrated ability to work well under time constraints and meet deadlines Demonstrated coordination, time management and communication skills Capable of conducting all start-up, active implementation, and closeout activities.
Level
Specific Requirements:
LEAD:
CRC Governance Committee review and approval Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
Minimum 5
years of directly related experience in clinical research and clinical trials is necessary Desired Qualifications 6
years of direct related experience Experience with the OnCore clinical trial management system (CTMS) Previous experience with MiChart, RedCap, and Qualtrics Work ScheduleMonday-Friday; hours vary depending on the study needs; general hours are within the 7am-6pm range.
Some evening (5pm-9pm) hours may be required depending on the study needs.
Work Locations Primary location is at the main medical campus in University Hospital South (UH South); with regular work activities at VonVoigtlander Women's Hospital.
This position may include some travel to Michigan Medicine clinical sites such as East Ann Arbor, Brighton, Chelsea, etc.
Some remote work may be allowed depending on study needs.
Additional InformationThe use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.
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 recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world.
We strive to create a work culture where each team member feels respected, valued, and safe.
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 DeadlineJob openings are posted for a minimum of seven calendar days.
The review and selection process maybegin as early as the eighth day after posting.
Thisopening 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.
#J-18808-Ljbffr Recommended Skills Administration Analytical Attention To Detail Auditing Billing Clinical Research Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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