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University of Rochester Human Subject Res Coord I - 225266 in Rochester, New York

Human Subject Res Coord I

Job ID

225266

Location

School of Medicine & Dentistry

Full/Part Time

Full-Time

Favorite Job

Regular/Temporary

Regular

Opening

Full Time 40 hours Grade 051 Cancer Center/Clin Trials Ofc

Responsibilities

Appropriate categories of patients served by the employee include:

  • Pediatric

  • 18-65 yrs

  • Over 65yrs

POSITION SUMMARY:

The Study Coordinator I (CRC I) is an entry level Clinical Research Professional who may have at least 1 years previous research-related work experience that instilled a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. Under the direction of the Principal Investigator (PI), Supervisor, Study Coordinator III (SC III), department program director, or designee, the SC I exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for simple clinical research protocols, and timelines.

SUPERVISION/DIRECTION RECEIVED:

Director Clinical Trials Office – Clinical Operations

TYPICAL DUTIES:

Managing the study 50%

  • Independently performs chart review/pre-screening for eligibility and coordination of simple clinical research protocols.

  • Maintains all logs, including onCore entry according to UR and department SOPs.

  • Assists planning study timelines and schedules appointments and study visits.

  • Manages and organizes case report forms, source documents and research records.

  • Conducts data collection activities according to established operational procedures and timelines.

  • Assists in observing and informing the PI/supervisor in a timely manner of adverse events, including those reported by study participants.

  • Fully adheres to established procedures, policies, and standards in implementing clinical research protocols.

  • Adheres to continuous research quality improvement practices.

  • Maintains safety, environmental, and/or infection control standards throughout job duties.

  • Assists in entering research data into data collection forms and/or study databases.

  • Assists in conducting quality checks for data accuracy with data source records as assigned.

  • Increases understanding of and interpreting moderately complex clinical study designs, research protocols, and procedures.

  • Executes simple clinical research protocols and may assist CRA1/CRDS in fundamentals.

  • Exhibits increasingly sound judgment in planning/performing research protocols for optimal quality research.

Maintaining Study Continuity and Coordinating Logistics, Research Procedures, and Study Participants 35%

  • Participates in pre-screening activities for study participant eligibility, maintaining enrollment procedures according to the protocol.

  • Observes, reports, and facilitates positive study participant responses, minimizing deviations.

  • Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.

  • Performs testing and data collection activities according to established operational procedures and timelines.

  • Observes for deviations and takes action to minimize them. Reports deviations when they occur, addressing adverse events with supervision.

  • Shows increasing organizational skills to facilitate full adherence to timelines.

  • Continues to learn how to recognize and report logistical challenges in protocol implementation to the research team, assisting in resolving challenges.

  • Assists in identifying and developing data collection tools. Assists the Data Manager in simple data tasks.

  • Performs quality checks for data accuracy, reports/follows-up with discrepancies.

  • Effectively collaborates with clinical services/departments to plan, implement, and evaluate study protocols.

Professional Development 5%

  • Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.

  • Maintains CITI and Conflict of Interest (COI) certification and renewal as required.

  • Gains knowledge in medical research terminology.

  • Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols.

  • Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in same.

  • Participates in protocol-related training as required.

  • Duties as assigned

Machines/Equipment Used:

  • Computer, Printer, Copier

REQUIREMENTS:

Education:

  • Bachelor’s degree (health-related field preferred).

  • Mandatory CITI training prior to participating in any research-related procedures.

Work Experience Requirements:

  • Minimum of 1 year of clinical research or relevant work experience.

  • Track record of commitment to advancing own expertise through education, training, and research experience.

  • Promotion to higher levels is not automatic as a result of longevity in position. Rather, promotion requires increased duties and responsibilities, departmental recommendation, and Human Resources approval

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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