Clinical Research Associate

Life in Pittsburgh; Pittsburgh (Allegheny County); Presencial; USD 60.000 - 90.000; Jornada completa

Descripción de la vacante

UPMC Department of Dermatology in Pittsburgh, PA is seeking a full-time Clinical Research Associate to support its Clinical Research team at 3601 Fifth Avenue, Falk Medical Building. The role works Monday–Friday, 8:00 a.m.

to 4:00 p.m., coordinating and supporting clinical research studies. Responsibilities include data collection, coordinating with investigators, preparing and tracking documents, obtaining consent, maintaining study records in CTMA, and ensuring compliance with protocols and

Formación

• Bachelor's degree in Business, Healthcare, or related field, or LPN with 2 years of clinical research experience.
• Alternatively, high school graduate with SOCRA or ACRP certification and at least 2 years of clinical research experience.
• Knowledge of MS Office and ability to work with PC databases; highly organized and able to work with minimal supervision.

Responsabilidades

• Coordinate and support clinical research studies.
• Create study calendars and review with PI and supervisor.
• Ensure prompt and accurate data collection for protocols.
• Assist with consent process and documentation.
• Enter data into CTMA and maintain study records.
• Support billing reconciliation to avoid improper charges.
• Participate in meetings and educational seminars.
• Verify eligibility by reviewing medical records, labs, radiology.
• Monitor protocol compliance and trial procedures.
• Collect follow-up data and survivorship information after study completion.

Conocimientos

MS Office

PC database systems

Organizational skills

Deadline-driven

Educación

B.A. degree in Business/Healthcare or related

LPN license with 2 years clinical research experience

SOCRA/ACRP certification + 2 years experience

High school diploma with SOCRA/ACRP cert + 2 years experience

Herramientas

CTMA

Descripción del empleo

UPMC Department of Dermatology is seeking a full-time Clinical Research Associate to support its Clinical Research team at 3601 Fifth Avenue, 5th Floor, Falk Medical Building, Pittsburgh, PA 15213. This position works Monday through Friday from 8:00 a.m. to 4:00 p.m. and plays a key role in coordinating and supporting clinical research studies.

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.

• B.A. degree in Business, Healthcare, or related or LPN license 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