Human Subject Research Coordinator - Study Coordinator II

Responsibilities

Appropriate categories of patients served by the employee include:

N/A Neonate

X Pediatric

X 18-65 yrs

X Over 65 yrs

Position Summary

The Study Coordinator (SC) II is a mid-level Clinical Research Professional responsible for assisting in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. Under the ultimate responsibility of the Principal Investigator (PI) and the mentorship of a Supervisor or more senior SC, the SC II assists in the day-to-day operations in the implementation of clinical research protocols. S/he will assist in carrying out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines and will assist in assuring the overall integrity of studies. S/he will assist in monitoring and adhering to standards, regulatory guidelines, and approved operational procedures; work closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols; help with study-related administrative tasks; facilitate across-the-board flow of information, and assist in coordinating study activities and personnel. S/he will also perform duties as assigned.

Supervision/Direction Received

Director Clinical Trials Office – Clinical Operations

Typical Duties

Managing the study 50%

• Performs study procedures, routine tests, data collection/recording, and “day-to-day” operations of moderate risk clinical research protocols

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

• Maintains study binders and filing according to protocol requirements and UM and department policy

• Accurately enters data; helps manage/organize case report forms, source documents, and study databases

• Assists in recruitment activities, and assists in screening potential study participants for eligibility

• Collects, processes/packs/ships specimens according to protocol, applicable standards and regulations

• Distributes study drug//materials according to practice standards, clinical credentials and as delegated by the Investigator

• Assists in safety and quality improvement efforts, minimizing risk/safety threats

• Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations

• Assists in implementing protocol amendments under direct supervision of the PI (if applicable)

• Assists with study orientation, protocol-related in-services to research team and clinical staff

• Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule

• Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, departments

• Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education; performance reviews

• Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.

• Assists in procuring needed supplies/materials

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

• Collaborates closely with clinical services/departments in protocol planning, implementation, and evaluation

• Assists in the responsibilities of study activities/protocol logistics among research team, study sites and clinical services

• Schedules and participates in Site Initiation Visits (SIV) and monitoring visits and participates in research team and PI oversight meetings as required.

• Assists in coordinating research team meetings; facilitates communications

• Assists in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected time-line

• Schedules, prioritizes study visits/procedures/clinical tests in synchrony with data collection activities according to established time-points; tracks progress of participants through protocol as well as overall study progression of the protocol

• Identifies, determines, documents, reports, and follows-up on protocol deviations, assists in discussing and carrying out approved corrective measures

• Assists in participant recruiting and retention strategies and follow-ups, maintaining contact with subjects between visits and using study visit reminders (as per protocol)

• Assists in study close-out procedures

Professional Development 5%

• Maintains requisite skills and mandatory training in safety, equality, responsible/ethical conduct of research training; continuing education, research competencies, certification as required

• Assumes personal responsibility for keeping abreast of new developments in the field, related literature, and research standards

• Anticipates protocol-related training/direction, assists in orienting new study team members

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 3 years of clinical research or relevant work experience (oncology experience preferred).

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

Competencies and Skills

• Increasing ability to understand and follow standard research protocols and procedures

• Increasing ability to understand and follow technical instructions for operating clinical research equipment.

• Increasing ability to adhere to applicable safety and/or infection control standards

• Increasing ability to understand and follow data integrity standards and processes; increasing ability to coordinate clinical research study protocols seamlessly

• Strong interpersonal, communication (verbal and written), and organizational skills

• Increasing ability to develop strong relationships with research participants/patients, some of whom suffer stressful, debilitating chronic health conditions

• Highly collaborative, works well in teams

• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet

• Fluent English language skills required (oral and written).

• Develops strong relationships with research participants/patients, some of whom suffer stressful, debilitating chronic health conditions.

• Highly collaborative, works well in teams

• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet

• Fluent English language skills required (oral and written)

Note: An equivalent combination of education and experience, which provides proficiency in the areas of responsibility listed above, may be substituted for the above education and experience requirements.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $ 45,800 - $ 64,100 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 053 Cancer Center/Clin Trials Ofc
Schedule: 8:30 AM-5 PM