University of Rochester Sr Human Subject Res Coord in Rochester, New York
Full Time 40 hours Grade 055 Medicine M&D-Gastroentrol; Div
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.
- Support the safety of research patients/research participants
- Comply with federal, state, institutional, and sponsor policies and laws, standard operating procedures (SOPs) and guidelines (Must possess knowledge of IRB and human subject protection)
- Adhere to an IRB approved protocol
- Understand and practice good clinical practice (GCP) and regulatory compliance
- Maintenance of required certification to conduct clinical research
- Participate in generating subject lab trends and study update reports as necessary
- Attend pre-study, site qualification, study initiation, monitoring visits, project-team meetings and multi-site activities
- Contribute to recruitment activities which include preparing recruitment materials and screening, recruiting and enrolling patients/research participants
- Adhere to Study Drug Administration and Compliancy
- Educate subjects and family members on protocol and study procedures.
- Participate in the informed consent process of study subjects
- Coordinate and/or perform protocol related research procedures, study visits, and follow-up care
- Maintain study-related data, case report forms, and necessary documentation
- Report and document adverse events as appropriate
- Act as liaison for research subject, investigator, sponsor, and healthcare professionals
*As Human Subject Research Coordinator III: *
- Assist the senior coordinator in approving study source documents pertaining to protocols, assist in creating budget preparation materials, and create informed consent documents
- Prepare and submit IRB documents, continuing reviews, amendments, and protocol deviations.
- Assist in implementing and creating in house standard operating procedures and training the study staff
- Assist in supervision of the student employees and level I coordinators
- Coordinate pre-study, site qualification, study initiation, monitoring visits, project-team meetings and multi-site activities
- Assist in training Level I clinical research coordinators and students
- Track certifications for study staff and lab equipment and lab certifications
Specific Duties for HSRC Level 3:
- Responsible for supervision and training of students, Level I, and Level II clinical research coordinators
- Initiate the start of Sponsored or Investigator studies - CDA, CTA, 1572, FDF, Protocol Review, ICF, Laboratory Manual, etc.)
- Oversee and manage IRB submissions and regulatory documentation
- Oversee pre-study, site qualification, study initiation, monitoring visits, project-team meetings and multi-site activities
- Create budget and Post Activity workbooks for study start-ups.
- Support ORPA's contract negotiation with sponsor
- Create and implement standard operating procedures and study staff training
- Manage study quality assurance activities such as certifications and trainings
- Manage laboratory equipment, shipping, and receiving.
- Manage study finances including sponsor invoicing & resolving study subject billing issues
- Attend leadership meetings and activities
- 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 Human Subject Res Coord
Location: School of Medicine & Dentistry
Job ID: 210361
Full/Part Time: Full-Time