GENERAL SUMMARY/ OVERVIEW STATEMENT:
Working closely with the Principal Investigator and other study staff, the Clinical Research Coordinator extracts and adapts patient information from the MGH electronic medical record (LMR and/or Epic) into Excel spreadsheets and other forms for use in a clinical study database on burn patients. Takes necessary precautions under HIPAA and the approved human studies protocol to ensure security and confidentiality of patient data. Must be motivated, organized and able to perform self-directed work. PRINCIPAL DUTIES AND RESPONSIBILITIES
- Screens newly admitted patient charts for eligibility into research study; refers results to principal investigator.
- Documents eligible patients in database and verifies patients continue to meet eligibility requirements for inclusion in study.
- Obtains informed consent from patients prior to study entry.
- Completes various study forms, including questionnaires to document patient information; enters into paper and electronic files; updates database with information as required.
- Completes data entry of data in a timely and accurate manner; performs quality control checks on data
- Maintains research files and enrollment logs, tracks patient data and monitors physicians' schedules for pre-op, surgery and post-op appointments of eligible patients
- Compiles patient data in an Excel spreadsheet, noting patient progress and trends for review by principal investigator.
- Provides study data and summaries to study leadership staff; updates study documents to incorporate all IRB or sponsor related protocol changes
- Participates in conference calls and other meetings to learn about study requirements and to provide study or data status reports.
- Tracks payments from study sponsors and works with grant manager to ensure payments are made to the practice.
- Serves as point person for clinical trials and works effectively with sponsors, study staff and/or other hospital departments.
- Engages in patient follow up to include tracking and distribution of questionnaires to ensure protocol compliance in long-term studies.
- Coordinates the collection of blood samples; utilizes centrifuge to process samples; coordinates specimen shipping; may process other study samples
- Collects, collates and submits documents to the IRB according to required format; includes protocols, continuing reviews, and amendments.
- In collaboration with the principal investigator, assists with preparing research grant applications, including compiling study documentation (e.g. data, progress summaries, expenditure tracking), CVs and other documents; ensures applications are completed to meet the grant specifications and submitted to meet grant deadlines; may write sections of grant proposals when requested.
- Assists principal investigator in writing and preparation of manuscripts for retrospective studies by providing data, charts and other documentation, gathering reference and other information and distributing copies for review.
- Responsible for monitoring strict adherence to study protocols and immediate written report of any protocol violations for submission to Medical Director of Burn Service
- Knowledge of clinical research protocols and familiarity with the consenting process for health research studies strongly preferred
- Ability to draft and/or revising Institutional Review Board (IRB) research protocols
- Ability to use laboratory equipment such as a centrifuge
- Math skills
- Computer literacy and accurate data entry skills
- Ability to follow directions and adhere to protocols
- Strong oral and written communication skills, organization and interpersonal skills
- Ability to work independently in a detail-oriented manner and solve problems with limited direct supervision
- Bachelor's degree required.
- Typically new graduate with relevant course or project work
Posting ID: 559420402Posted: 2020-06-03