Casual Clinical Research Associate

UPMC is hiring a Casual Clinical Research Associate to join their Critical Care Medicine team as part of their Multidisciplinary Acute Care Research Organization (MACRO) in Pittsburgh, PA!

The Multidisciplinary Acute Care Research Organization (MACRO) provides clinical trial services to principal investigators seeking to maximize the productivity and efficiency of acute care research, from the pre-hospital setting to the ICU and inpatient wards. MACRO offers a wide range of services, including 24/7 screening and enrollment into clinical trials and assistance in the conduct of prospective, observational, patient-oriented acute care research.

The Clinical Research Associate will be working in the ICU setting, coordinating interventional clinical trials alongside the APP, bedside nurses, and physicians, and drawing/processing blood samples from patients, overseeing data management of large-scale trials.

This is a casual position with no set schedule. This position will work daylight, evening, and overnight shifts depending on the type of patient enrolled into the clinical trial and protocol needs. This position is a hybrid work from home role, but all applicants must be located within 60 minutes of the Pittsburgh area or willing to relocate to this area for onsite needs.

Responsibilities:

• Create individualized study calendars and reviews them with the patient.
• Meet with the principal investigator and Clinical Research Coordinator/Supervisor to review patient status on as needed basis.
• Responsible for prompt and accurate data collection for protocols.
• Assist coordinator in preparing, sending and tracking documents for re-consenting patients.
• Participate in multi-disciplinary meetings to foster educational development by attending relevant seminars, conferences and sponsored educational events as required.
• In addition, will contact patient/family members to obtain follow up or survival data information after study completion, and will review survival record data bases to provide follow up. All follow up information is to be documented onto study CRFs and entered into CTMA.
• Assist in providing consent forms to coordinators and investigators so that the informed consent process is implemented with study subjects.
• Meet monthly with disease center research program leader and research team to present subject trial status.
• Facilitate entry of patient on to clinical trials by performing the following tasks.
• Complete research requisitions to assist billing department to prevent billing of research procedures to third party payers.
• Perform consenting process and study implementation of lab, registry, and non-therapeutic clinical trials.
• Perform trial related responsibilities as required such as processing, storing and shipping trial specimens, administers study related questionnaires to study participants (i.e. quality of life, etc.).
• Assist in entering subject trial registration and study status updates into CTMA.
• Insure that patient's records, slides, radiology tests, lab work results, etc. are obtained and reviewed prior to patient entry onto a study.
• Assist in verifying subject eligibility according to protocols by reviewing medical records, laboratory, and radiology or CT scan results.
• Complete financial review forms of potential patients to determine insurance coverage for standard of care procedures and completion of requisition forms.
• Create study specific source documents, case report forms and study visit checklists.
• Facilitate the enrollment of subjects to trials open to the community network sites and will follow up on outstanding data collections.
• Facilitate follow-up of protocol patients by developing maintenance-therapy data collection sheets for all protocol patients who require follow-up.
• Assist in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor.
• Monitor subject compliance of oral study medications.
• Assist with obtaining tumor measurements from Radiologist or Investigators to determine response information as per protocol.

Qualifications:

• B.A. degree in Business, Healthcare, or related or LPN license with a minimum of 2 years of clinical research experience OR
• High school graduate with current certification as a Clinical Research Associate from either the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) along with a minimum of two years of clinical research experience

Knowledge and use of MS office software products and the ability to work with PC database applications. Excellent organizational skills and be able to work on projects/tasks simultaneously. Highly motivated and be able to work with minimal supervision. Ability to adapt to multiple organizational structures. Ability to meet deadlines and be flexible in response to sudden workload changes.

Licensure, Certifications, and Clearances:

• Act 34

UPMC is an Equal Opportunity Employer/Disability/Veteran