Senior Health Project Coordinator - University of Rochester : Job Details

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

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:

400086 Peds M&D Hematology/Oncology

Work Shift:

HG - Weekend Day (United States of America)

Range:

UR URC 211

Compensation Range:

$59,208.00 - $82,857.00

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:

Coordinates and oversees the Pediatric Clinical Research Program within the Division of Pediatric Hematology/Oncology including the cooperative group protocols through Children's Oncology Group (COG) and Dana Farber Cancer Institute (DFCI), investigator-initiated, compassionate-use, and pharmaceutical research projects.

Directs the planning, implementation, coordination, operation and evaluation of divisional procedures required to ensure quality clinical trial research within the Division of Pediatric Hematology/Oncology. Must possess expertise in the area of Research Subjects Review Board (RSRB), Office for Human Research Protections (OHRP) and or Federal Drug Administration clinical research regulations.

At a local level, this individual must have the ability to devise the necessary strategic methods required to assure the success of the research projects. This person must have the ability to carry out strategic planning which incorporates the needs of the disciplines, the institution, the cooperative group, and the patient while abiding by the federal regulations.

Administration/Coordinator

* Coordinate and conduct the implementation of research studies to comply with cooperative group and national/local regulations. In this role, this person will serve as a liaison between the cooperative groups, departmental, and non-departmental personnel to assure that this institution is in compliance with study guidelines as detailed on the individual treatment protocols. Ensure timely completion of study documents. Phone communication and emails with cooperative groups, department and non-departmental personnel will be instrumental.

* Maintain protocols and associated documentation such as enrollment forms, eligibility checklists, adverse event reporting forms, and case report forms.

Data Management/Research

* Act as information resource to clinical staff for protocol specific queries. Over time, he or she will become familiar with the cooperative group protocols. At that time, he/she will be able to facilitate answering logistical questions pertaining to these studies such as eligibility questions, which protocols are open within this institution, knowing the status of the protocols, i.e. is the protocol temporarily closed to accrual.

* Confirm study eligibility and enroll patients into cooperative group trials. Will review the treatment protocol specific eligibility requirements and enrollment procedures which are provided on the individual studies.

* Review source documentation such as laboratory reports, operative notes, patient progress notes, and radiology scan result notes and record the results as per individual study guidelines. Ensure timely submission of this study data.

Regulatory

* Ensures compliance with acceptable regulatory requirements and IRB standards. The regulatory agencies include the University IRB, clinical trials office, and the FDA. Ensure integrity of all study data collected. Ensures protocol activities are administered consistently across all studies. Will prepare and submit protocols, amendments, and annual progress reports to the IRB in compliance with the specified timelines from the cooperative groups. Keeps up-to-date with current federal regulations for conducting clinical studies according to Good Clinical Practice (GCP) Guidelines. Keeps current with industry standards and therapeutic areas relevant to sponsored studies.

* Develop University IRB approved informed consent documents for all protocols. These consents are generated by modifying an existing consent document from the individual cooperative group protocol.

* Prepare for audits through the Institutional IRB which occur every 3 years. To prepare for an audit, he/she will collect all study documents for auditor review.

Qualifications:

Bachelor's degree with major course work in an appropriate health, social or technical field, 3-5 years of related experience; or an equivalent combination of education and experience.

Preferred Qualifications

* 2 years prior experience as a Senior Health Project Coordinator

* Certified Clinical Research Coordinator preferred

* Bachelor's degree in related field, or equivalent experience

* Ongoing commitment to professional development

* Knowledge of computer databases, word processing, spreadsheets, and graphics packages are important. No specific statistical program knowledge.

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.