University of Rochester Human Subject Res Coord II in Rochester, New York
Full Time 40 hours Grade 053 Pediatrics SCRC
8:30 AM-5 PM; WEEKENDS ONLY UPON ADVANCED SCHEDULING; NO EVENINGS UNLESS CLINIC VISITS EXTEND BEYOND WORK HOURS; SCHEDULE MAY VARY BASED ON OPERATIONAL NEEDS.
THIS POSITION HAS AN END DATE OF 7/31/19.
This position will work under the direction of the Principal Investigator and PCRO Director Operations and Regulatory Affairs and provide study coordination services for clinical trials (pharma and industry sponsored) with broad latitude for autonomy and independent judgment. Responsible for implementation of study protocols, identifying and consenting research subjects, acting as resource for research subjects and their families. The position will be expected to organize multiple projects, allocate resources, monitor progress, and meet multiple competing deadlines. Coordinates, monitors, and oversees all phases of a large number of complex pharmaceutical sponsored studies within the Division. The position will be expected, as studies warrant, to interface with multiple sites for multi-center sponsored studies including travel for investigator meetings and conferences. Area travel required as part of subject enrollment.
Work on an independent level making primary decisions related to research specific implementation. Work collaboratively in the development of research protocols and consents. Initiate the process of IRB (RSRB or WIRB) research protocol review by completing and submitting the necessary components of the IRB application. Review sponsor contracts for submission to ORPA. Provide knowledge and skills to successfully maintain proper study activities. Maintain continuous relations with study team and principal investigator. Demonstrate ability to develop and maintain good clinical practice, division goals and objectives and utilize expert skill and knowledge to deliver safe and through research subject care. Demonstrates ICARE* values in each of the major responsibilities.
- Independently develop diverse study protocols (guidelines for study conduct), study designs, and consent forms for review by Principal Investigator and Research Staff. Plan and draft study specific documentation (Consent Forms, data collection sheets, etc.), recruitment (based on Inclusion/Exclusion specific criteria, medical history, age, requirements of study) and scheduling of subjects for study specific procedures, providing or assisting in study procedures such as obtaining blood/urine specimens, collecting vitals, EKG’s, etc.).
- Directs and conducts the implementation of research studies. Works with Principal Investigator and Research Staff, coordinators at regional and national sites to establish study start-up and on-going maintenance. Communicate with regional and national sites on study progress/problems. In this role, serves as a primary liaison between the sponsors, departmental, and non-departmental personnel to assure that institution is in compliance with study guidelines as detailed on the individual treatment protocols.Coordinate and implement study closure
- Notification to study subjects of study results and un-blinding, lab results
- Notification of primary MD of subjects in study, un-blinding, and drug administration
- Provides direct management and day-to-day care to subjects per Good Clinical Practice Guidelines (GCP), sponsor Protocol guidelines and good standard of care guidelines.Creates and performs QA/QC procedures.
- Ensure timely and accurate completion of study documents (Informed Consent, Clinical Research Forms, study specific databases) required by study sponsor and regulatory bodies.The maintenance of phone communication (including conference calls) and emails with sponsors, departmental, and non-departmental personnel as required concerning study status, enrollment, study issues/problems) will be instrumental in the sharing and dissemination of critical study information. This sharing of study information will be on a local, regional and national basis.
- Writes study manuals and study specific Standard Operating Procedures (SOP’s) which govern procedures and how study will be conducted. Implements SOP’s and ensures adherence to established SOP’s.
- Identify actual or potential study issues, develop problem solutions, and reformulate study goals on an as need basis.
- Maintain protocols and associated documentation such as enrollment forms, eligibility checklists, adverse event (AE) reporting forms, and Case Report Forms (CRF), study and regulatory binders for GCP and for sponsor, study monitors.
- Confirm study eligibility utilizing Inclusion/Exclusion Criteria and enroll patients into the appropriate study.Track and ensure that subject enrollment goals are met and all study measures are collected. Review the study protocol specific eligibility requirements and enrollment procedures which are provided on the individual studies.
- This involves preparation of study binders, creating and updating case report forms and/or source documents/ materials (protocol, ICF, randomization, enrollment form, etc.) and maintenance of documentation
- Train and provide supervision/guidance to new study staff as directed, when necessary by supervisor. Assist in monitoring progress (or lack of progress) for new staff. Identify personnel issues and areas of needed training; assist in making recommendations to PI and/or Research Staff to resolve personnel issues.
- Order, track and submit appropriate UR forms/documentation for participant incentives/reimbursement, study medications (medication log), device monitoring (device log) and study office supplies. Review and submit travel logs for self, PI and Research Nurses.
- Monitor study budget for spending and financial compliance (monitoring of study expenditures). Review study budgets justifications to ensure spending is within budget parameters. Develop invoices to submit to sponsors to obtain reimbursement for study services provided. Prepare and submit bills from other departments/services for study procedures conducted. Works with administrators to ensure payments received and verify accuracy to follow-up on non-payments or inaccurate payments.
- Ensures fidelity of transactions. Reviews and submits travel logs and other research staff’s financial paperwork. Ensuring accuracy, tracks receipts and provide necessary financial information to Pediatric Finance Office, ORPA of URMC Finance Department.
- Serve as liaison between PI, Research Staff, pharmaceutical company, study site, sponsor and/or governmental agencies. Will be contact personnel for sponsor, regulatory authority, etc. for study related questions/issues.
- Designs, develops, implements, monitors and manages systems and methods to ensure quality, safety, efficiency and consistency in the processing of data. Reviews study progress, including data, finances, timeframes, documentation and reporting desirables. Manages, implements and monitors systems for tacking and evaluating study progression.
- Participates in, or conducts, Investigator site qualification and initiation visits for sponsored studies. Prepares site documentation, schedules time/place of meeting, and assembles all appropriate documentation required for site qualification or study monitor visit. Serves as primary liaison during these visits.Does same for study monitor visit(s) per protocol/contract guidelines. Study start-up or monitor visits can be from 1-3 days in duration.
- Attend with PI and/or Research Staff, or represent the PI/Research Staff, at sponsor Investigator Meetings for new study start-up, annual study maintenance meetings, or for on-going study maintenance. Meetings can be local, regional or national.
- Act as information resource to study staff within the Division or sponsor for protocol specific queries. Be able to facilitate answering logistical questions pertaining to these studies such as eligibility questions, which protocols are open and accruing subjects and, knowledge of the status of the protocols. Meet and/or communicate with study sponsors/monitors.
- With a high level of independence and decision making, makes decisions at meetings on behalf of the Principal Investigator and/or Research Staff.
- Summarize study results in report and tables, so that it can be easily understood and disseminated to others. Design, create posters and either present or assist in presenting at study sponsored and scientific meetings, local, regional, national and international depending on sponsor.
- Create or utilize data collection forms (based on study), such as chart abstraction form, paper-based or on-line surveys, Case Report Forms. Develop (create) and maintain study-specific databases as necessary. Some database forms are developed by the sponsor, others will need to be developed by the coordinator for study parameters. Ensure integrity of all study data collected for sponsor submission to FDA and for eventual publication or, presentations as scientific or study sponsored meetings.
- Create database repository for monitoring study subjects participating in studies or for collating study data. This will be used for study data analysis, sponsor requirements or for study monitor visits. Analyses of data for integrity and reporting of unexpected outcomes to study sponsors. Prepares reports based on analyses as required by study sponsor(s).
- Review source documentation such as laboratory reports, patient progress notes, etc., and record the results as per individual study guidelines to ensure study data integrity.Ensure timely submission of study data per sponsor/funder requirements.
- Ensure compliance with acceptable regulatory requirements and IRB/WIRB standards.The regulatory agencies include the University IRB, clinical trials office, and the FDA. Ensure integrity of all study data collected.Ensure protocol activities are administered consistently across all studies.
- Will independently prepare and Initial RSRB Applications, submit protocols, and annual progress reports to the IRB/WIRB in compliance with the specified timelines as required by the UR RSRB Office, from the sponsor or cooperative groups.
- Independently writes and submits amendments to the RSRB when changes are needed to study procedures and/or measures.
- Corresponds/interacts with IRB/WIRB on an ongoing basis to ensure that correct procedures are completed in regards to human subject’s research. Primary contact (initial study staff member contacted) between research team and regulatory authorities.
- Maintains accurate and appropriate regulatory binders for GCP, sponsor and regulatory review/site visits.
- Reviews adverse event (AE) reports and/or Action Alerts (alerts from the sponsor for appropriate action to protect subject safety) and to maintain regulatory compliance with UR IRB Office/guidelines. Submit AE Report to IRB/WIRB to comply with University regulatory compliance.
- Develop University IRB/WIRB approved informed consent documents for all protocols.These consents are generated by modifying an existing consent document from the individual cooperative group protocol.Maintain appropriate version control of all documents.
- Prepare for audits through the Institutional IRB/WIRB, study monitor or the FDA. To prepare for an audit he or she will collect all study documents for auditor review and maintain availability to auditor throughout duration of review. Audits/monitor visits are variable depending on sponsor requirements. Visits may be from 1-3 days in duration.
- Train staff on RSRB/regulatory guidelines and how to utilize University of Rochester RSRB Website as well at the Western Institutional Review Board (WIRB) Website.
Bachelor’s degree and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience. Knowledge of word processing and data analysis software. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) desirable. Experience as Human Subject Research Coordinator II preferred. Must have reliable/efficient transportation. Travel to local, regional conferences and meetings required as well as to off-site GI Clinic location on weekly basis. Area travel required. Demonstrates desire and initiative to increase knowledge and skills in clinical research. HSPP required.
Clinical research experience, pediatric, strong computer skills. Excellent communication skills, telephone skills, and ability to work in a multi-faceted team environment. Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.
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. Must possess effective communication, organization and decision-making skills as well as maintain accurate and complete records on all subjects for sponsor review. 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 as well as the ability to interact effectively with a wide range of individuals including patients, adolescents, peers, clinical/researchers at all levels.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord II
Location: School of Medicine & Dentistry
Job ID: 208805
Full/Part Time: Full-Time