| Location | Cleveland, OH |
Salary Grade
Case Western Reserve University is committed to providing a transparent estimate of the salary for this position at the time of its posting. The starting wage rate is $20.68 per hour, depending on qualifications, experience, department budgets, and industry data.
Employees receive more than just a paycheck. University employees enjoy a comprehensive benefits package that includes excellent healthcare, retirement plans, tuition assistance, paid time off, and a winter recess.
Job Description
POSITION OBJECTIVE
Working under general direction from the Principal Investigator, the Research Project Coordinator will coordinate adult and pediatric clinical and translational research studies within a pulmonary and critical care and pediatric critical care research programs focused on sepsis, hemolysis, immune dysfunction, cardiovascular injury, and critical illness. This individual will serve as a central operational resource for studies conducted through Case Western Reserve University, University Hospitals of Cleveland, and collaborating sites. Responsibilities include maintaining central IRB materials, assisting with new IRB submissions, managing REDCap study databases, screening, consenting, and enrolling patients, coordinating study activity across sites, and supporting biospecimen movement from the clinical setting to the laboratory. The position requires direct interaction with clinical teams, research staff, patients, families, laboratory personnel, and collaborating investigators across adult and pediatric studies. The coordinator must be able to obtain and maintain required University Hospitals of Cleveland credentialing, Case Western Reserve University training, and research access for work across the Case Western Reserve University and University Hospitals research environment.
ESSENTIAL FUNCTIONS
Coordinate daily operations of adult and pediatric clinical and translational research studies. Oversee day to day logistics for multiple concurrent studies involving critically ill adult and pediatric patients. Coordinate screening, enrollment, study visit timing, specimen collection windows, data collection milestones, and communication with the Principal Investigator, clinical teams, laboratory personnel, and collaborating sites. Maintain study calendars, recruitment logs, enrollment trackers, delegation records, and study status updates. Identify barriers to study execution and communicate operational issues promptly so that protocols remain aligned with approved procedures and project timelines. (25%)
Maintain central IRB and regulatory documentation and assist with new IRB submissions. Maintain central IRB records, regulatory binders, reliance documentation, training documentation, study approvals, continuing reviews, amendments, reportable events, and protocol deviation documentation for adult and pediatric studies. Assist the Principal Investigator and research team in preparing new IRB applications, protocol summaries, consent forms, amendments, renewals, and supporting documents. Coordinate submission materials across Case Western Reserve University, University Hospitals of Cleveland, and external sites as required. (25%)
Manage REDCap databases, data entry, and data quality workflows. Enter, monitor, and maintain study data in REDCap and related approved research systems. Support creation and maintenance of REDCap instruments, data dictionaries, surveys, reports, and study logs under direction of the Principal Investigator and study team. Perform routine data quality checks, resolve missing or inconsistent data, maintain participant confidentiality, and ensure data collection is consistent with IRB approved procedures, sponsor expectations, and institutional requirements. (20%)
Support patient screening, enrollment, and study coordination in clinical settings. Assist with identification of potentially eligible patients using approved screening workflows in adult and pediatric clinical environments. Coordinate with clinical teams to support patient approach, consent workflows, enrollment activities, and study procedures as allowed by protocol, training, and institutional policy. Communicate respectfully and professionally with patients, families, clinicians, coordinators, and study personnel. Maintain accurate screening and enrollment documentation and protect patient privacy at all times. (15%)
Coordinate biospecimen transport, chain of custody, and preliminary sample processing. Coordinate movement of blood and other approved biospecimens from clinical areas to the research laboratory. Maintain chain of custody documentation, specimen labeling, time stamps, and storage records in accordance with approved protocols and laboratory standard operating procedures. Perform preliminary sample handling after appropriate training, including sample receipt, basic processing, centrifugation or spin down of samples, and delivery to designated laboratory personnel for downstream analysis. (10%)
NONESSENTIAL FUNCTIONS
Facilitate communication, credentialing, and cross site coordination. Maintain required University Hospitals of Cleveland credentialing, Case Western Reserve University compliance training, human subjects research training, and access to approved systems needed for study coordination. Assist with communication across Case Western Reserve University, University Hospitals of Cleveland, and collaborating sites to support aligned study operations. Participate in study meetings, prepare updates for the Principal Investigator, document action items, and follow through on assigned study tasks. (5%)
Provide orientation and task based guidance to new staff, trainees, and student workers regarding approved study workflows, REDCap entry expectations, specimen tracking procedures, and regulatory documentation practices. Perform other related duties as assigned in support of the translational pulmonary and critical care research program. (<1%)
CONTACTS
Department: Frequent contact with project investigators and staff to collaborate on projects and gain feedback.
External: Frequent contact with student workers from multiple external universities assisting with projects.
University: Regular contact with principal investigators and faculty, especially within School of Medicine to exchange project information.
Students: Occasional contact with student workers and interns from multiple universities involved with projects.
SUPERVISORY RESPONSIBILITY
This position has no direct supervision of staff employees. May provide task direction, workflow guidance, and orientation support to student workers, trainees, and temporary research personnel as appropriate.
QUALIFICATIONS
Education/Experience: Bachelors degree in a health related field, biological sciences, public health, clinical research, or related field and 2 years of related work experience required. Prefer 1 or more years of experience supporting clinical research, research coordination, project coordination, or small team workflows. Must be able to obtain and maintain University Hospitals of Cleveland credentialing, Case Western Reserve University research training, and system access required for assigned studies.
REQUIRED SKILLS
Experience with human subjects research, clinical research operations, and biospecimen coordination strongly preferred.
Experience working in adult or pediatric hospital settings preferred.
Strong project management skills with ability to coordinate multiple active adult and pediatric studies, prioritize deadlines, and follow through on assigned tasks.
Knowledge of human subjects research principles, IRB documentation, consent workflows, privacy requirements, and regulatory record maintenance.
Experience with REDCap data entry, data quality review, report generation, and database maintenance, or demonstrated ability to learn these systems quickly.
Ability to assist with new IRB submissions, amendments, continuing reviews, reliance documentation, protocol deviations, and study start up materials.
Ability to interact professionally with patients, families, clinical teams, investigators, coordinators, laboratory personnel, and external collaborators.
Ability to maintain confidentiality, follow HIPAA requirements, and handle sensitive clinical and research information with discretion.
Ability to follow approved biospecimen handling workflows, maintain chain of custody records, transport samples, and perform preliminary spin down or processing after training.
Strong written and verbal communication skills, including ability to prepare clear study updates, regulatory summaries, and meeting notes.
Strong organizational skills, attention to detail, accuracy, time management, and ability to adapt to changing study priorities.
Proficiency with Microsoft Office Suite, Google Workspace, REDCap, electronic records, and willingness to learn additional institutional research systems.
Ability to meet consistent attendance requirements and occasional schedule variability driven by patient enrollment or specimen collection needs.
Ability to interact with colleagues, supervisors, research participants, families, and clinical teams face to face.
Ability to demonstrate successful support, education, and advocacy for all students, aligned with the values, mission, and messaging of the university, while adhering to the staff policy on conflict of commitment and interest.
Willingness to learn and work with Artificial Intelligence (AI) tools and technologies.
WORKING CONDITIONS
General office, clinical research, hospital, and laboratory environments. The position may involve work in adult and pediatric clinical areas, research offices, and laboratory spaces at Case Western Reserve University and University Hospitals of Cleveland. Work may require walking between clinical and laboratory areas, standing for periods of time, use of PPE, transport of biospecimens, and handling of biological specimens according to approved standard operating procedures. Occasional schedule variability may be required based on active enrollment, specimen timing, or study needs.
EEO Statement
Case Western Reserve University is an equal opportunity employer. All applicants are protected under federal and state laws and university policy from discrimination based on race, color, religion, sex, sexual orientation, gender identity or expression, national or ethnic origin, protected veteran status, disability, age and genetic information.
Reasonable Accommodations
Case Western Reserve University complies with the Americans with Disabilities Act regarding reasonable accommodations for applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the CWRU Office of Equity at 216-368-3066 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicants will be made on a case-by-case basis.
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