The Center for Biomedical Research is a clinical research site management organization that serves as a liaison between the pharmaceutical industry and physician groups to make innovative and relevant clinical research available to patients throughout East Tennessee.
We are currently seeking a Regulatory Data Management Specialist. This position is responsible for coordinating review by the Institutional Review Board (IRB) of research proposals/protocols under which human subjects may be involved, compiling protocol information and ensuring compliance with federal regulations. This position will also be supporting the activities of the Principal Investigator in accordance with federal, state, local, and any other appropriate guidelines, policies and procedures. Data management as directed by clinical research manager may be required as well, which could include developing case report forms for investigator initiated trials, transcribing data from EMR to CRF’s, register and maintain patients enrolled in clinical trials, and assist clinical research coordinator with daily functions of research team.
- Prepare and maintain all regulatory information for IRB.
- Analyze protocol information necessary to write patient consent forms, conferring with principal investigator and sponsor on language required.
- Assure compliance with FDA and IRB regulations.
- Assure necessary forms, licenses/CV’s, and labs are maintained and updated as required to meet regulatory guidelines.
- Provide regulatory documents during study initiations, auditing and closeout visits. Establish, update, and maintain study binders. Correspond and assist study monitors and personnel via fax, phone, and email.
- Prepare, generate, update and distribute data reports to physicians, team members and sponsors.
- Communicate with clinical research team members regarding new studies, timelines, and upcoming changes to the protocol.
- Maintain patient database, including registering patients enrolled in clinical trials.
- Participate in all team quality assurance and performance improvement projects. Prepare and participate in program audits.
- Prepare and participate in site visits, and assist study coordinator’s in collection, storage, and shipment of patient specimens, radiology reports, radiology scans, and other items as needed.
- Retrieve all patient data in its various forms—prior histories, inpatient admissions, ER visits, outpatient visits, referring MD office records, scans, pathology for data input onto the case report forms
- Prepare and maintain clinical research charts for each protocol patient, ensuring processes are compliant with SOPs.
- Retrieve, identify and enter clinical research data in a timely manner each day.
- Communicate effectively with physicians, patients, IRB, monitors, contract research organizations, and sponsors utilizing good interpersonal skills regarding the status of current and potential clinical trials.
- Participate in the orientation and training of new staff involved in the implementation and management of clinical trials.
- Participate in the development and management of quality assurance and performance improvement activities within the program.
Required Experience & Skills:
- Graduate of an accredited college or university with Associate's degree of science. Bachelor's degree is preferred.
- Seeking ACRP or SoCRA certification within two years of hire; ACRP or SoCRA certified preferred.
- Experience in clinical research required. Oncology and/or Radiation Therapy experience is preferred.
- Minimum of 1 year of medical office, clinic, hospital or other medical work.
- Ability to manage multiple tasks and prioritize accordingly.
- Possess excellent written and oral communication skills, as well as mathematical skills including arithmetic and algebra.
- Demonstrate general computer proficiency, report generation, form design and document editing abilities
- Proficient computing skills including Microsoft Suite, electronic medical records & data management software
- Ability to gather, organize, and verify data for projects.
- Understand basic knowledge of pathophysiology and psychopathology as relates to oncology and other disease processes.
- Ability to maintain attention to detail to avoid errors of a technical or judgmental nature.
- Maintain confidentiality of data and patient information according to HIPPA regulations.
- Ability to work independently and as part of a team, while also having excellent interpersonal skills.
- Indoor outpatient office setting
- Clinical procedure areas
- Extended amounts of time in front of a computer
The Center for Biomedical Research is committed to providing physicians and healthcare organizations with seamless and innovative clinical research solutions to benefit and improve patient outcomes. The principal focus of CBR is clinical research program is to serve the health care industry through providers, CROs, pharmaceutical companies and other life science enterprises in support of observational/registry trials and Phase II through Phase IV clinical studies. The programs uniqueness and attractiveness lies in offering distinct services to companies in need of clinical trial support. In addition to patient and physician access through multiple clinical trial oncology practices, CBR is capable of offering full site management services to health care providers, trial sponsors as well as clinical research organizations.
Location/Region: Knoxville, TN (US)