University of Rochester Sr Health Project Coord in Rochester, New York
Full Time 40 hours Grade 055 Ortho, Clinical Research
8 AM-4:30 PM
Under the direction of the Supervisor/Administrator and the principal investigator, with latitude for independent judgment, this individual will have responsibility for managing clinical research trials. The trial sponsors are 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 supervise health project coordinators. This person will be expected to function independently on a daily basis.
- Directly supervise other Health Project Coordinators. Train study mentorship. Handle performance issues, perform annual reviews and administer corrective action.
- Perform Health Project 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 regulatory agencies including WIRB, RSRB, GCRCC, and FDA. Prepare reports including IND applications and those for FDA and IRB. Assist in design of protocols. Assist in preparation of grants and submission to government agencies.
- Obtain informed consent including drug intervention trials. Provide detailed teaching for drug risk and potential side effects. Evaluate subjects 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, may perform phlebotomy. Perform patient visits.
- Act as a point person for all assigned studies when principal investigators are not available. Use clinical judgment in reviewing labs and adverse events and reports them appropriately. Prepares serious adverse event reports.
- Code data for purpose of data entry. Review and respond to data queries. Maintain data and safe keeping of clinical patient data.
- Coordinate efforts of collaborating investigators. Assists PI's with training to assure compliance. Represent our center at appropriate meetings. Work with study sponsors.
- Work with Administrator/Supervisor to assign workload. Direct effort of individual studies.
- Prepare, authorize and maintain budgets. Coordinate expenditure control. Assign and manage personnel percent effort.
- BS degree in related field and/or combination of education and related research experience.
- 3-5 years Clinical Coordinator experience although 5-7 years experience preferred with strong leadership skills.
- Strong interpersonal and leadership skills, clinical and computer skills are necessary.
- Phlebotomy experience preferred.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Sr Health Project Coord
Location: School of Medicine & Dentistry
Job ID: 209189
Full/Part Time: Full-Time