Job Description

POSITION OBJECTIVE

Working independently under the general direction of the Principal Investigator (PI), the Research Associate serves as Clinical Trial Project Manager for a federally funded randomized clinical trial evaluating a tablet-based emotion-regulation intervention for surrogate decision makers of critically ill adults as patients transition from intensive care to hospital wards. The Research Associate leads day-to-day operational implementation of the study, including study startup and activation, regulatory coordination, research personnel management, participant recruitment and retention, intervention delivery, participant safety reporting coordination, and project administration. This position requires independent judgment, initiative, and the ability to anticipate operational challenges, establish effective research workflows, monitor study performance, and coordinate a multidisciplinary research team. The Research Associate is responsible for implementing solutions within the approved protocol, institutional requirements, delegated authority, and available project resources. The trial will draw upon infrastructure developed for a related clinical study. The Research Associate will evaluate and adapt existing regulatory documents, standard operating procedures, training materials, data systems, intervention resources, and study management tools to meet the requirements of the new protocol and clinical setting. The Research Associate is expected to manage routine study operations independently while promptly escalating scientific decisions, proposed protocol changes requiring approval, significant participant safety concerns, major personnel matters, and other issues requiring PI or institutional authorization.

ESSENTIAL FUNCTIONS

1. Develop and Maintain Study Infrastructure and Regulatory Compliance. Coordinate study start-up and activation. Translate the funded research protocol into operational workflows, implementation timelines, staffing plans, training requirements, and study management procedures. Evaluate and adapt to existing research infrastructure, which may include regulatory documents; create standard operating procedure manuals and/or update existing manuals, intervention materials, recruitment tools, data systems, and study management resources. Develop additional study-specific procedures and materials as needed. Coordinate regulatory activities, including preparation, submission, tracking, and maintenance of Institutional Review Board (IRB) applications and amendments, continuing reviews, required study documentation, ClinicalTrials.gov information, and other applicable sponsor or institutional submissions. Maintain complete, accurate, current, and audit-ready regulatory files, delegation, and training records. Monitor study activities for adherence to the approved protocol, Good Clinical Practice (GCP), human subjects’ protections, institutional policies, sponsor requirements, and applicable regulatory standards. Identify protocol deviations, compliance concerns, and operational risk. Coordinate documentation, corrective actions, and required reporting through established procedures. Proposed changes to approved research procedures must receive all necessary PI, IRB, sponsor, or institutional approvals before implementation. (20%)
2. Coordinate research staffing needs and participate in recruitment, interviewing, and selection activities in collaboration with the PI, Human Resources, and other applicable university offices. Coordinate onboarding, required credentials, clinical site access, study-specific training, and competency assessment for research personnel. Provide day-to-day direction to assigned research personnel, including work assignments, staffing and coverage plans, scheduling, workload coordination, and monitoring of study-related responsibilities. Establish clear expectations and provide ongoing instruction, coaching, performance feedback, and consistent, accurate, and protocol-compliant research practices. Monitor staff competency, adherence to study procedures, completion of assigned responsibilities, and emerging staffing or performance concerns. Document and elevate matters requiring formal personnel action through the PI and applicable university processes. Establish effective team communication and accountability practices, including regular study meetings, operational updates, training records, and follow-up on assigned action items. List them in descending order of importance and indicate the percentage of time spent on the duties. (25%)
3. Develop and coordinate participant-facing study operations across participating intensive care units and receiving medical-surgical or stepdown units, including screening, eligibility determination, subject recruitment, informed consent, enrollment, intervention delivery, and follow-up. Establish and maintain systems to track participant flow, recruitment and enrollment targets, study visits, retention, and other indicators necessary to evaluate study performance. Monitor recruitment and retention against study targets, identify operational barriers, emerging patterns, and opportunities to improve participant engagement and study coordination. Develop and implement appropriate workflow improvements. Maintain effective working relationships with clinicians, research personnel, and hospital unit leadership. Coordinate study activities with clinical workflows to support appropriate, efficient, and respectful interactions with patients, surrogates, decision-makers, and families. Maintain sufficient familiarity with participant-facing research activities to train personnel, assess competency, evaluate study performance, troubleshoot operational issues, and provide coverage when appropriately trained, authorized, and needed. (25%)
4. Oversee Data Quality and Participant Safety. Must oversee the completeness, accuracy, timelines, security, and integrity of study data and source documentation across REDCap, study devices, tracking systems, and other approved research platforms. Establish and maintain quality assurance procedures for data review, protocol fidelity, documentation, and the identification and resolution of recurring operational or data quality concerns. Coordinate, follow up on, and report on participation in safety events in accordance with the Data and Safety Monitoring Plan, IRB requirements, sponsor requirements, and applicable institutional policies. Review study performance and quality indicators, communicate findings to the PI, and coordinate any corrective or preventive actions within approved procedures and delegated authority. (15%)
5. Support project administration and budget management. Maintain overall visibility into study progress, milestones, deadlines, additional staffing needs, resource requirements, and operational risk. Provide the PI with timely information needed for project-level decisions. Monitor project expenditures and anticipated resource needs; support budget forecasting and coordinate purchasing, equipment, inventory, and related fiscal activities with the PI and the designated FPB Department of Finance. Coordinate routine administrative activities with grants administration, finance, sponsored programs, hospital partners, vendors, and other internal and external offices to support timely study operations. Prepare progress reports, enrollment summaries, and fiscal and operational reports. Contribute, as appropriate, to presentations, manuscripts, dissemination activities, and related research products. Support responsible stewardship of grant resources and budgetary commitments and purchasing approvals. (10%)

NONESSENTIAL FUNCTIONS

1. Complete and maintain required Collaborative Institutional Training Initiative (CITI) human subjects research certification, good clinical practice training, University Hospital credentialing and health screening requirements, and other training or credentials required by the university, hospital, IRB, sponsor, or study protocol. (2%)
2. Maintain current knowledge of relevant institutional, regulatory, sponsor, privacy, clinical site, and research compliance requirements. (2%)

CONTACTS

Department: Continuous contact with PI, co-investigators, research staff, graduate research assistants, and other study personnel to plan, coordinate, supervise, troubleshoot and evaluate clinical trial operations

University: Occasional to regular contact with Human Resources, grants and finance personnel, the IRB, sponsored programs, research, IT and other administrative department to coordinate staffing, regulatory, data, technology and fiscal requirements.

External: Frequent contact with University Hospitals clinicians, research personnel, intensive care and hospital unit leadership, sponsor representatives, independent study monitoring personnel, and study related vendors to coordinate trial implantation and resolve operational issues.

Students: Regular contact with graduate research assistants and student employees to provide training, assign and coordinate related work, monitor performance, and support research activities.

SUPERVISORY RESPONSIBILITIES

The Research Associate provides operational leadership and day-to-day direction to research personnel assigned to the clinical trial, including staff and graduate research assistants and other study personnel. Responsibilities include coordinating onboarding and training, assigning and monitoring work, establishing staffing and coverage plans, providing coaching and feedback, identifying retraining needs, and participating in performance and personnel processes under the direction of the PI and in accordance with university procedures. The Research Associate is expected to exercise sufficient operational leadership and independent judgment to enable research personnel to perform their assigned responsibilities without routine direct management by the PI.

The annual starting base salary range for this position is from $52,000 to $80,000. CWRU considers factors such as (but not limited to) scope and responsibilities of the position, candidate’s work experience, education/training, key skills, internal peer equity, as well as market and organizational considerations when extending an offer. University employees enjoy a comprehensive benefits package that includes excellent healthcare, retirement plans, tuition assistance, and paid time off.

Qualifications

QUALIFICATIONS

Experience: At least three (3) years of progressively responsible, relevant experience, including substantial responsibility for coordinating clinical or behavioral research operations. The candidate must demonstrate experience in research project coordination, human subjects protections, regulatory or IRB processes, implementation of research protocols, research data management, and the training or direction of research personnel.

Experience with several of the following is required, with specific combination evaluated against the position’s responsibilities:

Study startup activation, and ongoing clinical trial operations.

Translation of research protocols into operational workflows and procedures.

IRB submissions, regulatory documentation and research compliance

Research personnel training, work coordination and performance oversight

Research data management, quality assurance and protocol fidelity monitoring.

Coordination of research activities within healthcare settings

Education/Licensing: Master’s degree in a health, behavior, social, clinical, public health, nursing, psychology, research or closely related field required, subject to confirmation of the university’s applicable Research Associate appointment requirements.

REQUIRED SKILLS

1. Clinical research project management: Demonstrated ability to independently coordinate complex human subjects research, manage multiple interdependent workstreams, ability to establish priorities and timelines.
2. Protocol operationalization and problem-solving: Ability to translate research protocols into practical workflows and procedures, anticipate operational barriers, identify appropriate solutions, and implement changes within the boundaries of the approved protocol.
3. Regulatory and human-subjects research knowledge: Strong working knowledge of Institutional Review Board requirements, Good Clinical Practice, human-subjects protections, regulatory documentation, protocol deviations, and other requirements applicable to clinical research.
4. Research team leadership and supervision: Demonstrated ability to train, supervise, coordinate, and manage the performance of research personnel, including providing clear expectations, feedback, and accountability.
5. Participant-facing clinical research operations: Knowledge of participant screening, eligibility determination, recruitment, informed consent, enrollment, intervention or study-procedure delivery, retention, and follow-up within clinical research settings.
6. Data quality, protocol fidelity, and research oversight: Ability to oversee study documentation, data completeness and accuracy, adherence to study procedures, participant-safety processes, and preparation for monitoring, quality-assurance review, or audit.
7. Organization, initiative, and independent judgment: Excellent organizational, time-management, prioritization, and problem-solving skills; strong attention to detail; and the ability to distinguish matters that can be resolved independently from those requiring escalation to the Principal Investigator.
8. Communication and research technology: Excellent written, verbal, and interpersonal communication skills, including the ability to work effectively with research participants, families, clinicians, investigators, staff, students, and administrators; and the ability to use or learn clinical and research systems such as REDCap, Epic, and study-related technology.

WORKING CONDITIONS

Work is based in the Principal Investigator’s research offices in the Dental Research Building, 2124 Cornell Road, Cleveland, Ohio, and in adult intensive care units and receiving medical-surgical and step-down units at University Hospitals Cleveland Medical Center.

The position combines clinical trial project management and research administration with regular on-site activity in hospital clinical areas. Although Research Assistants and other trained study personnel will perform many participant-facing research activities, the Research Associate must maintain sufficient direct familiarity with clinical operations to effectively supervise screening, recruitment, informed consent, enrollment, intervention delivery, participant follow-up, protocol adherence, and staff performance.

Regular on-site presence is required, and the position is not eligible for fully remote work. The incumbent should expect to move between the research office and hospital units during the workday.

The usual work schedule is Monday through Friday, approximately 8:30 a.m. to 5:00 p.m., with flexibility required to accommodate participant recruitment, enrollment, intervention delivery, follow-up, staff supervision, and other time-sensitive study activities.

The incumbent must comply with applicable University, University Hospitals, Institutional Review Board, HIPAA, infection-control, and clinical-environment policies and procedures.

No routine laboratory hazardous-material exposure is anticipated. Work in hospital environments may involve exposure to infectious diseases and other clinical-environment risks mitigated through standard hospital infection-control procedures.

Application Instructions

Applicants should submitt a current curriculum vitae or resume and a cover letter describing their qualifications and relevant experience. Applications will be reviewed on a rolling basis until the position is filled.

Equal Employment Opportunity 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 Accommodation Statement:

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 Office of Equity by phone at 216.368.3066 or by email at equity@case.edu. Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.