Human Subject Res Coord I
Rochester, NY
Responsibilities
Job summary:
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.
Job responsibilities include, but are not limited to the following:
Duties and responsibilities:
20% of time will be spent:
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
20% of job will consist of:
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
20% of assignments include:
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
20% of duties will be:
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
10% of duties:
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
10% of job duties:
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
Minimum education:
Requires a minimum of a Bachelor's Degree or equivalent. Prior clinical trial experience preferred.
Minimum related experience:
This opportunity is ideal for individuals who will be applying to residency, foreign medical graduates, or individuals with a graduate health sciences degree and a minimum of 4+ years of clinical research experience.
Minimum computer skills:
Working knowledge of MS Office
Experience with statistical analysis programs (ie. SAS, SPSS, STATA) is preferred
General skills:
Qualifications for Candidates include but are not limited to the following:
Candidate will ensure integrity and compliance with all regulatory, institutional, and departmental requirements
The ability to take initiative and work independently is required, and the ability to effectively work in a complex matrix is required
Outstanding technical writing skills and understanding of medical terminology/research
Advanced understanding of data management processes
Ability to analyze and interpret scientific data and skilled in the use of computerized systems and databases
Ability to understand and follow scientific research protocol and procedure
Excellent communication skills (both verbal and written) required
Exceptional organizational, interpersonal, and presentation skills
Ability to understand and follow complex, detailed technical instructions
Ability to foster a cooperative & collaborative work environment
The ability to be flexible with scheduling is mandatory; willingness to work evenings and weekend hours in unusual or emergent situations required.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $21.36 - $29.90 Hourly
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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