Develops, coordinates and manages the operational, regulatory, financial and analytic requirements for longitudinal research studies of patients, and for additional research studies that involve interventions that impact health outcomes and cost of care.
Bachelors degree in nursing, healthcare, healthcare administration or a related field of study required. Master’s degree preferred.
Six (6) years of experience working with patient care processes, as a clinician, researcher or professional in a clinical support service.
Experience working in clinical research, preferably as a clinical research coordinator/manager, including research consenting and management of protocol requirements preferred.
Experience working with data collection, database management, and preparation of research reports preferred. Experience designing research data collection tools preferred.
Three (3) years of experience working with patients.
Experience managing IRB and research regulatory submissions and documents preferred.
Project management experience preferred.
Equivalent Education and/or Experience
Additional experience with patient care or clinical research may substitute for the minimum education requirement.
Certification from a research-related professional organization (ACRP, HCCA, SoCRA, etc.) preferred.
Registered nursing license preferred.
Required Tests for Placement
Skills or Special Abilities
Knowledge of Microsoft Office Products (Word, Excel, PowerPoint) and other office software.
Knowledge of SPSS, RedCap and/or other database management and analytics software preferred.
Knowledge of research terminology, design, study methods, ethics, and risk assessment.
Strong analytic and computer skills in addition to knowledge of word processing, database management and spreadsheet software.
Ability to demonstrate effective interpersonal skills and possess good and oral written communication skills.
Ability to communicate effectively with physicians, nursing and ancillary staff.
Ability to demonstrate patient centered/patient valued behaviors.
Spanish language skills preferred
Must have evidence of completion of training in Human Subjects Protection (HSP), Good Clinical Practices (GCP), HIPAA and other required research modules required by the IRB and by Parkland.
Assists with the development of new study protocols, operational processes and supporting documents. Identifies and analyzes the design of jobs, work processes, work flows, etc. for the study (and the program) and implements appropriate changes to improve effectiveness, productivity, and efficiency that support the overall goals of the program.
Coordinates the submission of documents to the Institutional Review Board (IRB). Maintains IRB correspondence, submits modifications, tracks approvals, and ensures compliance. Also ensures compliance with Parkland site approval through the Office of Research Administration.
Develops and maintains individual subject study files and a master study regulatory file (including protocol(s), regulatory documents, study delegation and authorization log, approved consent and HIPAA authorization templates, study procedures, approved patient materials (including questionnaires), and study site approval documents.
Recruits patients for research studies ensuring subject eligibility; screens patients; explains the study purpose and content of each study; obtains research informed consent and HIPAA authorization in accordance with Good Clinical Practices. Assists in resolving problems relating to patient care and acts as a study subject advocate by providing educational materials and appropriate guidance related to research activities.
Develops procedures for inpatient and outpatient research activities; follows protocol-specified schedule of tests and procedures; ensures procedures are performed under the direction of the principal investigator. Monitors and evaluates patients involved in research studies, including their response to therapy and reports any adverse events and protocol violations.
Administers surveys; tracks visits and study communications with subjects; collects data from the subjects, the electronic medical record, paper records and other sources. Responds to requests for study data and prepares reports to physicians or sponsoring agencies in compliance with the study protocol and approvals.
Develops and monitors budgets, annual goals and objectives, and expenditures to ensure the study (and program) has the necessary funds to carry out the goals and objectives that have been established.
Other duties as assigned which may include the following: Preparing for and coordinating regulatory monitoring/auditing visits and responding to outstanding items; working with external sponsors to set up studies; assisting with grant applications; providing training and inservices related to research activities; ensuring patients are identified in the Clinical Trial Management System (Velos CTMS) and the Electronic Medical Record (EMR), and that executed consent and HIPAA authorization forms are filed in the patient’s EMR. Assists in the development of data collection instruments; systems for managing data (Excel, Redcap, or other programs); and standardized reports. Develops and implements processes to ensure security and confidentiality of study data.
Identifies ways to improve work processes and improve customer satisfaction. Makes recommendations to supervisor, implements, and monitors results as appropriate in support of the overall goals of the department and Parkland.
Stays abreast of the latest developments, advancements, and trends in the field by attending seminars/workshops, reading professional journals, actively participating in professional organizations, and/or maintaining certification or licensure. Integrates knowledge gained into current work practices.
Maintains knowledge of applicable rules, regulations, policies, laws and guidelines that impact the area. Develops effective internal controls designed to promote adherence with applicable laws, accreditation agency requirements, and federal, state, and private health plans. Seeks advice and guidance as needed to ensure proper understanding.
Parkland Health and Hospital System prohibits discrimination based on age (40 or over), race, color, religion, sex (including pregnancy), sexual orientation, gender identity, gender expression, genetic information, disability, national origin, marital status, political belief, or veteran status.
Nearest Major Market: Dallas
Nearest Secondary Market: Fort Worth
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