Summary: Performs routine administrative and patient care support duties to assist medical/research staff in the examination and treatment of patients and execution of Research related tasks. Provides research related administrative laboratory and patient care support duties to assist the research department with research protocols through pharmaceutical companies by performing the following duties
Duties and Responsibilities include, but are not limited to, the following:
Serves as primary contact for research protocols as assigned by PI and Director of Research. Assumes responsibility of ensuring adherence and proper execution of all protocol procedures and accurate collection of data.
Screens patient records, databases, and physician referral summaries for identification of prospective candidates for research protocols. This includes working with an Interdisciplinary Team of case managers, pharmacy and HCV program staff to identify and review suitable study candidates.
Participates in Site Assessments, Pre-study Visits, Site Initiation Visits, Investigator’s Meetings, ongoing Monitoring Visits for assigned protocols (may involve travel).
Completes study related activities according to timelines as directed by Director of Research, Investigators and sponsors.
Coordinates research patient visits ensuring that all procedures required by protocol are completed appropriately while adhering to Good Clinical Practices (GCPs). Procedures involved include, but are not limited to; lab kit and source document preparation, obtaining and recording medical histories, collecting vitals, physical examinations, phlebotomy, intensive PK visits, performing ECGs and specimen processing and shipping.*
Meets with patients during study visits to review ongoing adverse events, concomitant medications, study drug accountability and adherence, and other study related materials and information, and schedules future visits in accordance with protocol time and events schedule.
Manages the collection of medical and study related data from each patient visit, accurate completion of case report forms (CRFs) and source documents, and subsequent data entry and query resolution in protocol specific data capture systems within 24-72 hours unless otherwise specified/agreed on with Director of Research, PI and Sponsor.
Participates in the use of Interactive Web Response Systems (IWRS) and Interactive Voice Response Systems (IVRS), to obtain research subject randomizations, screen failures, drug dispensing assignments, registering research subject visits and acknowledging investigational medication shipment receipts.*
Responsible for the timely and appropriate management of study related lab reports, documentation of relevant patient medical and drug histories, on-going concomitant medication and adverse event logs, appropriate management of study related dangerous drugs and study drug receipt, dispensing and return accountability logs, and drug storage temperature logs.
Maintains proper documentation and record of communications with sponsors, monitors, patients, and physicians, including telephone and email correspondence to support the legal and ethical execution of clinical trials.
Schedules and undergoes sponsor initiated monitor visits and quality assurance audits for periodic review and query resolution.
Participates in ad hoc audits, Continuous Quality Management, and process improvement activities as directed.
Monitors and reports on all protocol specific issues and patients to the PI, Director of Research, Investigators, and the research team.
Functions as an integrated member of the Research and Interdisciplinary Care Team to enhance exceptional patient/subject care and safety.
Completes work with a focus on quality and integrity, recognizing need for critical attention to detail.
Engage research community professionally when representing SCC’s program, both locally and nationally.
Engage in ongoing professional development, and request assistance and/or additional training as required.
Performs other clinical and administrative functions as delegated and supervised by Medical Practitioners and Director of Research.
Participates in HIV and Hep-C testing as assigned
Other duties as assigned
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Language Ability: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Math Ability: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills: To perform this job successfully, an individual should have knowledge of Microsoft Office Suite; database software; and electronic data capture systems as appropriate per protocol. Proficiency in the following computer skills:
Basic operation of workstations (turning on/off, knowledge of basic functions and components)
Use/storage/maintenance of multiple usernames and passwords
Use of Windows Explorer (electronic file-handling)
Use of Microsoft Office Suite 2010 (Word, Excel, Outlook)
Computer-related problem-solving skills through use of available trainings/help desk
Associate’s degree or equivalent from two-year college or technical school (two-year degree in nursing or a health care related field preferred); and/or
One to two years related experience and/or training; and/or
Equivalent combination of education and experience
Proficiency in Spanish language preferred
Certificates and Licenses:
Participates in annual OSHA training and HIPAA training
Southwest CARE Center:
Health Care Every Person Deserves
Founded in 1996, Southwest CARE Center (SCC) is well known as a center of excellence for the care and treatment of people living with HIV in New Mexico. SCC is the largest provider of treatment for people living with Hepatitis C in northern New Mexico. SCC is the largest clinical research site in New Mexico for studies of new treatments f...or both HIV and Hepatitis C. In September of 2015 SCC opened its doors in Albuquerque providing the same high standard of HIV care SCC is known for.
We have expanded our scope of services to include a full array of primary health care services across the life span with the same high standard of comprehensive care.
Our Services include –
Pediatrics and Family Medicine
Adult Internal Medicine and Infectious Disease
Comprehensive women’s health services
HIV and Hepatitis C research and treatment
Primary care and specialty pharmacy services
Reproductive health for men and women
Prevention, education and testing for HIV & Hep C
Our focus at Southwest CARE Center is to provide a compassionate, patient-centered environment where everyone can feel comfortable and respected while receiving the highest quality health care available.
SCC is funded in part by the U.S. Department of Health and Human Services, Health Resources and Services Administration - HIV/AIDS Bureau and the New Mexico Department of Health.