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Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400117 Neurorestoration Institute

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.36 - $29.90

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.

Responsibilities:

The University of Rochester Neurorestoration Institute is seeking an individual for the position of Clinical Coordinator. The main role of the Clinical Coordinator will be to operate & maintain the day-to-day operational duties of their assigned clinical trials and clinical research study database. The primary role of this position is to support the Clinical Research OT position in the University of Rochester Neurorestoration Institute.

Duties and responsibilities:

• Assist the Director and OT in the preparation of study budgets, research related cost estimate forms, and initiation of all new research studies and trials

• In collaboration with the other clinical coordinators, develop day-to-day plan and procedures for data collection as well as data confidentiality and data security for research coordinators and techs.

• Develop plans for protocol implementation, identify necessary resources and request as appropriate. This includes instruments, equipment and staff.

• Determine recruitment objectives and develop systems to monitor and track achievement

• Assistance in the preparation and submission of annual reports and regulatory information to funding and regulatory agencies

• Assist the regulatory team with the preparation of IRB applications and ongoing IRB activities

• Preparation and submission of regulatory documentation to the regulatory bodies as relevant

• Assist investigators with validation and editing of collected data

• Analyze study data and assist in preparing manuscript

• Regular collaboration with the PI and other research staff

• Maintenance of study documents and files, such as regulatory binders and CVs etc.

• Completion of GCP, HIPPA and applicable regulatory training

• Complete certification requirements for assigned protocols

• Screen designated schedules or patient lists for eligible subjects

• Approach and verify eligibility subjects

• Scheduling of research visits

• Training of patients on robots and oversight of patients on these protocols

• Processing, transporting and shipping of biological specimens as assigned and following of instructions as delineated in the protocol or manual of operations.

• Completion of study documents and files; some examples might include case report forms, worksheets and medical record notes.

• Maintain confidentiality of documents and files such as HIPPA.

• Maintenance of detailed study files & complete paper case report forms & uploading of electronic case report forms/data within 48 hours of collection

• Obtain fully informed consent of all eligible trial & study patients in accordance to IRB, local & federal statutes

• Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions); data is collected through medical chart review, recording of physiologic, imaging data, structured interviews with patients and family members, and conducting all follow up visits in strict accordance with protocol specifications

• Working with regulatory coordinator in submitting new protocols, amendment, renewals, and other regulatory submissions to IRB, sponsor, FDA, and other regulatory bodies.

• Instruct, oversee, and ensure appropriate coordination of day-to-day aspects of study related procedures for research coordinators and techs, including, but not limited to: scheduling study subject visits and procedures, data entry, preparation for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, and preparation for monitoring visits, site initiation/closeout visits and audits as needed

• Instruct, oversee & ensure appropriate coordination of research staff handling & processing of human bio-specimens such as blood, saliva, and stool

• Carry out required staff training and provide the direct supervision for two patient care technicians

• Provide on-boarding training and guidance for all new research staff

• Collaborate with patient care technicians and other study members to ensure consistent measures and protocols are being administered

• Informing relevant clinical staff regarding subject protocol participation.

• Clear and effective communication with potential study subjects, clinicians, other health care providers, ancillary staff, and research office staff

• Working with the other research managers in developing and overseeing the "on call" system for research staff to cover all active clinical studies

• Monitor and track achievements of clinical trials

• Scheduling follow-ups and documentation with patients as well as informing patients of other clinical trials and services offered

• Assist in other research related activities and projects as needed

REQUIREMENTS:

Requires a minimum of a Bachelor's Degree or equivalent. Prior clinical trial experience preferred.

Minimum computer skills:

• Working knowledge of MS Office

• Experience with statistical analysis programs (ie. SAS, SPSS, STATA) is preferred

EOE Minorities / Females / Protected Veterans / Disabled:

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.

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Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.

If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals

At the University of Rochester, we commit to diversity, equity, and inclusion and united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.