CLINICAL RESEARCH COORD B
Duties: Clinical Research Coordinator is required to manage multiple trials and supervise clinical research coordinators, research assistants and research students/interns for the Department of Neurosurgery at Pennsylvania Hospital (PAH) with HUP with PPMC cross coverage. The primary focus will be the Brain Tumor and Tissue Bank protocols as well as support of the Spine and Functional Neurosurgery protocols at PAH Neurosurgery Clinical Research Division (NCRD).
Responsibilities will include clinical, regulatory and budgetary and managerial duties:
1. Clinical Trial Management- Obtains patient consent, subject scheduling, supports the OR as required by protocol, abstraction of medical information from charts into online databases. Reviews case report forms with research nurse and lead CRC coordinating the clinical trial on an ongoing basis and makes corrections as needed. Clinical data entry for specific NCRD studies Organize and collect specimens and transport. Assists in packing and sending specimens to contract laboratory services. Tracks delivery and receipt. Administers questionnaires, personality tests, quality of life assessments or other surveys or inventories. Assists with screening & enrollment procedures. Guides subjects to
various departments for tests and procedures. Performs telephone follow-up procedures
2. Regulatory- preparation, submission and monitoring of human subjects protocols, and progress reports. Maintains and keeps records of credentials. Maintains active credentials in BCLS, JCAHO, HIPPA, UPHS Patient Oriented Research Certification Program, Patient Safety Program and all mandatory requirements.. Prepares for monitoring visits by the Sponsor, FDA or any governing regulatory agency (internal or external) scheduled to review the clinical research trials of the NCRD. Communicates in a timely manner all serious Adverse Events verbally/written to study sponsors and the IRB. Participates in investigator/coordinator meetings, site surveys and staff meetings.
3. Budgetary support of new and on-going clinical trials- developing clinical trial budgets, communicating with hospital and vendors for quotes for services.
4. Manage research assistants and summer students/interns
Position is contingent on continued funding.
Qualifications: A Bachelor's Degree in a biomedical related field and 2-4 years of related experience, or equivalent combination of education and experience, are required. Applicant must complete SOCRA certification within one year of employment. Applicants should demonstrate excellent organizational, communication and interpersonal skills, and must be competent and comfortable working with patients. Must be able to multi-task and shift from one part of the project to another depending upon priority.
Reference Number: 40-25132
Salary Grade: 026
Employment Type: Exempt
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research