Clinical Research Coordinator Associate

University of Michigan; Ann Arbor (MI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Excellent health coverage

Retirement match 2:1

On-site work environment

Job summary

The University of Michigan Kellogg Eye Center's De Lott Research Group seeks a Clinical Research Coordinator - Associate to support multi-institutional studies on chronic ocular pain and related neuro-ophthalmic conditions. You will assist with recruitment, regulatory tasks, data management, and study visits under Dr.

Lindsey De Lott and the team. Ideal candidates have a Bachelor’s in health sciences or a related field, 2+ years of clinical research experience, strong communication and

Qualifications

• Bachelor's degree in health sciences, public health, psychology, neuroscience, clinical research, nursing, social science, or a related field; equivalent experience accepted.
• Two years of directly related clinical research experience.
• Mastery of CRC-Technician duties or equivalent on CRC ladder is expected.
• Experience with regulatory documentation and IRB processes.
• Strong communication skills and attention to detail.

Responsibilities

• Coordinate study activities for multiple prospective, multi-institutional studies.
• Assist with recruitment, informed consent, enrollment, and follow-up.
• Manage regulatory documents and ensure protocol compliance.
• Support data management and entry into study databases.
• Collaborate with PI, investigators, and staff across sites.

Skills

Communication skills

Attention to detail

Organization

Independent work

Teamwork

Education

Bachelor's degree in health sciences or related field

CRC/CRA certification eligibility

Tools

REDCap

Microsoft Office

Job description

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.

The cover letter should address your specific interest in the position, outline skills and experience that directly relate to this position and provide three references with full contact information (name, phone number, e-mail address). If you are not providing a reference from your current position, please explain why. Applications without a complete cover letter will not be considered.

Mission Statement

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 Summary

The De Lott Research Group in the Department of Ophthalmology and Visual Sciences at the University of Michigan Kellogg Eye Center is seeking a detail-oriented, highly motivated, and compassionate Clinical Research Coordinator - Associate. The coordinator will support prospective, multi-institutional clinical research studies focused on chronic ocular pain and other neuro-ophthalmic conditions.

This position will work closely with Principal Investigator Dr. Lindsey De Lott, another clinical research coordinator, co-investigators and research staff at collaborating institutions, and clinical partners. The coordinator will support participant recruitment and retention, study visits, regulatory and data-management activities, and the execution of established protocols and workflows. A key responsibility will be assisting the group's other coordinator with quantitative sensory testing and other portions of study visits

The successful candidate will be dependable, organized, attentive to detail, and able to manage multiple responsibilities while working independently within established procedures and collaboratively as part of a multidisciplinary team. Strong communication, follow-through, participant-centered professionalism, and the ability to identify and elevate issues appropriately are essential.

We value different perspectives and are committed to fostering a collaborative environment in which every team member can thrive and contribute to our collective success.

CRC Statement

This clinical research coordinator (CRC) position may 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 elevate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Responsibilities*

Independent knowledge, skills, and abilities within all eight competency domains are expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations and Good Clinical Practice
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Responsibilities will include, but are not limited to, the following.

Clinical Research Coordination

• Understand protocol elements and requirements and accurately implement study procedures.
• Coordinate assigned activities for multiple prospective, multi-institutional studies involving chronic ocular pain.
• Execute study procedures independently or with minimal supervision, consistent with training, delegation, and protocol requirements.
• Support participant identification, screening, recruitment, informed consent, enrollment, scheduling, study visits, and follow-up.
• Serve as a point of contact for assigned participants, studies, or study teams.
• Communicate professionally and compassionately with research participants and their families.
• Track participant progress, study visits, procedures, questionnaires, and follow-up activities.
• Support participant-retention activities and follow up on missed or incomplete study activities.
• Triage routine participant questions and concerns appropriately and elevate clinical or safety concerns to qualified study personnel.
• Anticipate and help mitigate the potential for protocol noncompliance.
• Identify, document, and elevate protocol deviations, operational barriers, and recruitment or retention concerns.
• Participate in study start-up, active enrollment, follow-up, and closeout activities.
• Maintain study inventories and coordinate study equipment, supplies, and participant materials.
• Apply established research workflows, standard operating procedures, manuals of procedures, checklists, and job aids.
• Assist with orienting research staff and students to established study procedures, as assigned.
• Conduct or assist with standardized quantitative sensory testing procedures after completing required training and competency assessment and as permitted by study delegation.

Study and Site Management

• Support coordination and communication among the PI, participating institutions, clinical collaborators, and other stakeholders.
• Assist with participating-site start-up and activation by collecting and tracking regulatory, training, and readiness documentation.
• Schedule, prepare for, and attend study-related meetings, including site-initiation meetings, monitoring visits, audits, investigator meetings, and research-team meetings.
• Prepare agendas, meeting materials, minutes, action-item lists, and study updates.
• Track study milestones, deliverables, recruitment goals, site documentation, and assigned action items.
• Maintain organized and version-controlled study files using approved systems.
• Coordinate the distribution and tracking of study manuals, equipment, supplies, and participant materials.
• Support monitoring visits, audits, and study closeout activities.
• Complete participant-payment and reimbursement documentation accurately and in a timely manner.
• Assist with purchasing, vendor coordination, shipment tracking, and expense reconciliation in accordance with University policies.

Research Data Coordination

• Collect, enter, and maintain research data in accordance with the protocol, source-documentation requirements, and study data-management plan.
• Document data according to attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available?or ALCOA-C?principles.
• Create and maintain participant-tracking tools, source documents, case report forms, surveys, and study logs.
• Build or update REDCap instruments and databases using established specifications and under the supervision of the Data Manager.
• Escalate complex data discrepancies to the appropriate PI and data-management personnel.
• Support secure data transfer and data harmonization across participating institutions.
• Prepare routine recruitment, enrollment, retention, study-progress, and data-quality reports.
• Assist with data preparation for presentations, abstracts, manuscripts, and sponsor reports.

Regulatory Coordination and Participant Safety

• Apply Good Clinical Practice, institutional policy, and applicable regulatory requirements to assigned study activities.
• Assist with preparation and submission of Institutional Review Board applications, amendments, continuing reviews, reportable events, and study-closure materials.
• Assist in drafting and updating informed consent documents, protocols, recruitment materials, standard operating procedures, and participant-facing materials.
• Maintain regulatory binders and essential documents as outlined in Good Clinical Practice and other applicable guidelines.
• Track approvals, expiration dates, required training, delegation logs, and participating-site documentation.
• Support multi-institutional regulatory activities, including reliance documentation and single-Institutional Review Board processes when applicable.
• Appropriately identify, document, and report adverse events, serious adverse events, Other Reportable Information and Occurrences, protocol deviations, and unanticipated problems according to established reporting pathways and timelines.
• Monitor adherence to approved study protocols and elevate compliance or participant-safety concerns promptly.
• Assist with responses to monitoring findings, audit findings, and corrective and preventive action plans.
• Maintain participant confidentiality and comply with applicable privacy and information-security requirements.

Communication, Teamwork, and Professionalism

• Collaborate with Dr. Lindsey De Lott, research coordinators, investigators, clinical teams, collaborating sites, students, and other research personnel.
• Communicate study needs, progress, risks, and unresolved issues clearly and promptly.
• Work independently within assigned responsibilities while recognizing when guidance or escalation is needed.
• Demonstrate reliability, accountability, professionalism, and respect in interactions with participants and colleagues.
• Use available resources, tools, job aids, and e-clinical technologies appropriately.
• Participate in continuing education and professional development consistent with the CRC?Associate role.
• Perform other related duties as assigned.

Supervision Received

This position reports to Dr. Lindsey De Lott within the Department of Ophthalmology and Visual Sciences at the University of Michigan Kellogg Eye Center.

Supervision Exercised

None.

Required Qualifications*

• Bachelors degree in health science, public health, psychology, neuroscience, clinical research, nursing, social science, or a related field, or an equivalent combination of related education and experience.
• Minimum of two years of directly related experience in clinical research or clinical trials.
• Coordinator experience and demonstrated mastery of duties associated with the CRC-Technician position on the Michigan Medicine CRC Career Ladder.
• Eligibility for certification through the Association of Clinical Research Professionals as a Certified Clinical Research Coordinator, the Society of Clinical Research Associates as a Certified Clinical Research Professional, or an equivalent approved certification.
• Experience conducting participant-facing clinical research activities, including recruitment, informed consent, enrollment, study visits, or follow-up.
• Working knowledge of Good Clinical Practice, human-subject protections, informed consent requirements, research documentation, and participant-safety reporting.
• Experience implementing clinical research protocols and following manuals of procedures and standard operating procedures.
• Experience with Institutional Review Board processes and regulatory documentation.
• Experience collecting, entering, reviewing, and resolving research data.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and virtual collaboration tools.
• Experience with REDCap or another electronic data-capture system.
• Strong written and verbal communication skills.
• Demonstrated attention to detail, organization, accuracy, and follow-through.
• Ability to independently prioritize assigned tasks and meet deadlines.
• Ability to recognize concerns, identify appropriate resources, and elevate issues requiring additional intervention.
• Ability and willingness to work on-site for participant visits.
• Ability and willingness to learn and perform standardized quantitative sensory testing after completing required training and competency assessment.
• Flexibility to accommodate occasional study activities outside standard business hours.

Desired Qualifications*

• Four or more years of directly related clinical research experience.
• Experience in ophthalmology, optometry, neurology, pain research, neuroscience, or another participant-facing clinical research setting.
• Experience conducting quantitative sensory testing, psychophysical testing, ophthalmic or neuro-ophthalmic assessments, or standardized pain assessments.
• Experience coordinating prospective, longitudinal, observational, or interventional studies.
• Experience with federally funded or investigator-initiated research.
• Experience supporting multi-institutional studies.
• Familiarity with single-Institutional Review Board and reliance processes.
• Experience with University of Michigan systems, policies, eResearch, and the Institutional Review Board of Michigan Medicine.
• Familiarity with medical terminology and electronic health record review for research.
• Experience preparing for monitoring visits or audits and responding to data or regulatory findings.
• Demonstrated ability to communicate effectively with faculty, staff, clinical personnel, research participants, and external collaborators.
• Experience training or orienting students or research staff to established procedures.

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

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes .

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 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 Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.