Sr Human Subject Research Spec

Rochester, NY

GENERAL PURPOSE:

Under the direction of the Research Manager, with latitude for independent judgement, this individual will have the responsibility for managing clinical research trials, from industry, NIH, foundations and internal funds. This individual will oversee the day to day operations of the clinical research, support personnel as well as participate in i) budget development, negotiation and implementation, ii) discussions with the human subjects review board and the University’s legal office, iii) ensure compliance with protocol procedures, iv) maximize efficiency in subject recruitment and data analysis, v) prepare reports on specific trials and vi) appropriately close out clinical trials that are complete. May include travel to study sponsor meetings and/or travel off-site to consent and or collect specimens/samples. This person will train and mentor Human Subject Research Coordinators. This person will be expected to function independently on a daily basis. The main duties of this individual will be to participate in protocol and consent form development, budget development, negotiation and implementation, discussions with the human subjects review board and the University's legal office, ensuring compliance with protocol procedures. They will have responsibility for overseeing administrative processes related to human subject research, maximizing efficiency in human recruitment, enrollment, and follow-up of volunteers while meeting regulatory, University and sponsor requirements for the projects. Other duties include data analysis, preparing reports on specific trials, and appropriate close out of clinical trials that are complete. May include travel to study sponsor meetings and/or travel off- site to consent and/or collect specimens/samples.

RESPONSIBILITIES:

  • Perform Human Subject Research Coordinator duties as needed and those requiring a higher level of expertise. Provide professional direction for assigned projects. Organize and plan project start up, including applying for IRB, GCRC and IBC approvals. Prepare documents for study sponsor and regulatory agencies including WIRB, RSRB, GCRCC and FDA. Prepare reports including IND applications and those for FDA and IRB. Assist in preparation of grants for submission to government agencies.

  • Creates, plans, develops, implements and manages study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas. Creates, develops, reviews and approves source documents, case report forms and study-specific procedures, manuals databases and documents.

  • Act as a point person for all assigned studies when Principal Investigator(s) are not available. Use clinical judgment in reviewing labs and adverse events and reporting them appropriately. Prepare serious adverse event reports.

  • Using knowledge of Good Clinical Practice standards, maintains data on patients entered into the study via interviews, questionnaire completion, chart review, specimen results, etc. Assures completeness, accuracy and applicability of data. Code data for purposes of data entry. Review and respond to data queries. Maintenance and protection of patient data.

  • Prepare, authorize and maintains a working knowledge of budgets. Prepare and submit Funding Proposals for sponsored trials to ORPA. Collaborates with the Clinical Research manager to control expenditures. Involved in Assigning and managing personnel percent effort and assigning workload.

  • Coordinate efforts of collaborating investigators. Assists Principle Investigator(s) with training to assure compliance. Represent our Center at appropriate meetings. Work with study sponsors.

  • Obtain informed consent, particularly as it relates to drug intervention trials. Provide detailed teaching for drug risk and potential side effects. Evaluate subject understanding of risk. Screen potential volunteers using clinical judgment in reviewing inclusion and exclusion criteria. Obtain detailed medical history. Order appropriate diagnostic tests according to protocol. Coordinate scheduling and execution of patient visits.

  • Perform tests according to research protocol, including phlebotomy, ECG, specimen collection, and functional measures as deemed necessary for each study protocol.

  • Develops, enforces, and continually improves the Department’s quality data and regulatory compliance plan. Ensures proper study documentation is on file in the investigators’ files for the Sponsor, IRB, FDA or other federal agencies.

  • Mentors and coaches research coordinators of various levels. Develops, delivers and monitors efficacy of training on the conducting of human subject research in accordance with approved protocols and in compliance with the

  • Good Clinical Practices (GCPs), including training on policies and practices used by sponsors for the purpose of meeting regulatory requirements

  • Involved in distributing responsibilities to other coordinators as needed by the department and as the internal environment changes. Acts as a back-up when the Clinical Research Manager is not available

  • Develops, documents and implements Standard Operating Procedures (SOPs) at all sites and ensures adherence to established SOPs.

Other duties as assigned.

QUALIFICATIONS:

  • Bachelor’s degree with major course work in an appropriate health, social or technical field required.

  • 5 year’s experience in human subject research coordination required.

  • or equivalent combination of education and experience required.

  • Experience as Human Subject Research Coordinator II preferred.

  • Word processing and data analysis software, interpersonal and leadership skills required.

  • Professional Research Coordinator certification (SoCRA or ACRP) preferred.

  • CLASP Certification preferred.

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: $59,197 - $82,888 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.

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