This position works as a Research Assistant on geriatrics research program(s) providing study management and support functions. Primary Responsibilities and Duties Incumbent functions as a Research Coordinator for assigned research studies, with authority and responsibility delegated for performance of the following: Patient Contact, Safety, and Security 60 percent 1) Participates in design of data collection instruments and procedures, selection of appropriate measures and techniques, study implementation, statistical analyses, and interpretation of results. 2) Attends training for study protocol, rating scales, and all required trainings. 3) Recruits and schedules human subjects for intake assessments and follow-up.
The patients belong to a complex patient population with pre-existing medical conditions. Working with this complex population often requires interaction with the patient's family members or caregivers. 4) Collects and extracts medical records for subjects in assigned research protocols. 5) Screen subject(s) against protocol requirements and takes medical history.
Must maintain confidentiality of patient medical records. 6) Administers baseline assessment and follow-up assessments according to research protocols and level of training. 7) Administers and scores diagnostic and neuropsychological tests including the Mini-Cog Assessment, Confusion Assessment Method (CAM), Study of Osteoporotic Frailty (SOF) Index assessment, Mini Mental Status Examination and Patient Health Questionnaire. 8) Conducts complex interviews with both patients and family members using a variety of interview probes, open-ended and closed-ended questions.
9) Maintains accurate records of interviews and all diagnostic tests and summarizes those results. 10) Performs diagnostic tests and procedures such as taking, recording and reporting vital signs, assessments of physical function and performing standardized diagnostic testing. 11) Performs a variety of difficult diagnostic tests and procedures. Makes determinations where instructions or guidelines are only general in nature and do not contain specific details.
12) Monitors patients for outcomes including adverse reactions and takes corrective action based on established policy and past experience. 13) Answers questions relating to protocols and determines appropriate action. More complex cases require additional scheduling, supervision, and follow-ups. 14) Secures patients for procedures as needed depending on study protocol.
Gains the trust, confidence, and cooperation of the study participants and provides feedback through procedures. 15) Applies clinical knowledge of dementia signs and symptoms in order to assess cognitive capacity and gauge subject competency to provide informed consent. 16) Recognizes adverse events and brings them to the attention of the PI. 17) Assembles project records.
Files individual documents or information in records. 18) Monitors quality of data and procedures and assures human subjects rights are protected. Maintains patients' confidentiality at all times. 19) Maintains accurate chart notes in the electronic medical record following all clinic contacts.
Assigns patient flags as required by study protocols. 20) Extracts, edits, and/or codes patient records or other pertinent research data. Retrieves patient information from other clinical/management settings and other computer systems. Research Study Support 40 percent 21) Programs databases for data entry of research questionnaires, booklets, data, and creates codebook for these databases.
Runs various computer programs to edit and clean data for analyses. 22) Maintains accurate and timely case report forms, source documents, and regulatory files. 23) Extracts and analyzes published and unpublished documents, patient records, and/or other pertinent research databases. 24) Collaborates in data analysis, report and manuscript writing.
Summarizes research data into meaningful statistical tables and narratives. 25) Travels occasionally for research purposes. 26) Organizes meetings within the research team and across different departments preoperative clinic) for project review and to maintain optimal communication. 27) Coordinates with departments, clinics, investigators and staff at outside institutions in collaboration with research projects.
28) Writes abstracts, protocols, and informed consents for submission to the Institutional Review Board (IRB). 29) Performs other duties as assigned by the PI. 30) Manages the duties and responsibilities of a part-time research assistant. Delegates responsibilities, coordinates division of labor, and organizes meetings to outline the assignment of research tasks.
31) Trains an assistant in clinical interview techniques, neuropsychological test administration, subject recruitment strategies, data collection/entry, and adverse event monitoring. 32) Regularly reviews the assistant's competency to ensure inter-rater reliability of test administration and validate the authenticity of data collection. Knowledge Required by the Position This position requires previous experience in a research setting working with human subjects, which was gained either through education or through on-the-job experience. Knowledge of the principles of health sciences research, including policies and guidelines involved with human subjects' studies including accreditation agencies, FDA, DHHA and PHS policies, regulations and guidelines.
Ability to convey in written format technical information regarding research study protocol, procedures, etc. in lay format for review by other individuals, including human subjects, patients, IRB members, IRB Coordinators, Principal Investigators, and Clinicians. Ability to coordinate effectively with other departments (e.g. preoperative clinic staff).
Knowledge of research study protocols and parameters as written in the approved VA IRB grant. Knowledge of the Human Research Protection Program (HRPP). Knowledge of recruiting and enrolling research participants into research studies. Knowledge of various data gathering and data management techniques, such as medical record extracting, data editing, coding and data entry and the ability to take this knowledge and integrate it into workable research plans.
Knowledge of research principles, application of the scientific method, and general data analysis. Knowledge of interviewing skill, including general interviews, structured diagnostic interviews, neuropsychological testing, and structured symptom rating scales pertinent to research protocol. Ability to communicate with research subjects, mid- and high-level PIs, managers, health care providers, system analysts, and IT personnel in order to obtain and relay information on research projects and their needs. Ability to establish priorities, work independently and know when to obtain guidance.
Ability to delegate responsibilities to and oversees the training and continued competency of an assistant. Ability to be flexible with work hours in order to coincide with patient follow-up assessments scheduled through other clinics or departments. Ability to operate common office equipment including computer, fax machine, copier, scanner, laptop, projection equipment, conference lines and other meeting software. Knowledge and ability to use common computer software including MS Office Suite (Acces, Outlook, Excel, Word, PowerPoint, etc).
Ability to develop, maintain, and analyze complex databases. Knowledge of the medical library resources and procedures at both the Medical Center and affiliated university. Ability to research and procure various types of reference materials. Ability to analyze, organize, and present orally and in writing complete and accurate information in a timely manner.
Knowledge of safety and emergency procedures. Knowledge of administering questionnaires to research participants over the phone, in person and through the mail. Knowledge of CPRS to review medical records, enter patient flags, enter notes, etc. Knowledge and ability to follow-up with research participants who express suicidal ideation.
Knowledge and ability to recognize cognitive impairment in an older adult population. Advances his/her knowledge and skills through continuing education and completes all mandatory review classes as required for the protection of human research subjects and application of good clinical practices. Incorporates information and plans from other health care disciplines with emphasis on research protocol procedures and outcomes while insuring compliance within regulatory framework. Performs as assessment of exclusion/inclusion criteria utilizing basic research protocol outline and plans immediate and long-term patient involvement in all aspects of clinical research studies including in/out-patient visits, procedures, treatments, and potential adverse events.
Individually makes evaluations and determinations on adherence to good clinical practices to achieve optimal research outcomes and applies human protection policy knowledge to the resolution of program compliance. Follows up on all abnormal lab work, radiology reports, etc. (especially as associated with centralized research site laboratories) and reports to the physician in a timely manner. Monitors clinical activities in areas such as therapeutics, mental health, pathology, radiotherapy, and surgery and informs investigator of any deficiencies and/or expectations to ensure correction of problems in a timely manner.
Assists with the compilation of resulting data, performs computations and prepares charts, tables and summaries of the data. Ability to carry out library research and exercise initiative in the design, execution and interpretation of relevant clinical trials. Performs clerical work associated with general application of initial submission, alteration, and/or renewal of research protocols and forms associated with clinical research. Uses Computerized Patient Record System and attends classes as needed to maintain currency in computerized record documentation.
Skill operating a computer photocopying equipment and facsimile machine and ability to learn spreadsheet and various supporting software within Research Service. Knowledge to appropriately source relevant data from internet sites/searches for information. Supervisory Controls The supervisor makes assignments by defining objectives, priorities, and deadlines and assists the employer with unusual situations which do not have clear precedents. The employee, having developed expertise in this area, is responsible for planning and carrying out assignments in accordance with instructions, policies, previous training, or accepted practices in the occupation, resolving conflicts as they arise, coordinating the work with others as necessary, and interpreting policy on own initiatives in terms of established objectives.
Guidelines The incumbent must be knowledgeable of written and unwritten policies and procedures and practices. The employee uses judgment in interpreting and adapting guidelines such as agency policies, regulations, precedents, and work directions for application to specific cases or problems. The employee analyzes results and recommended changes. Complexity Tasks, methods, and functions of this position are varied and complex and require multiple types of skills, adaptability, and excellent organization.
Accuracy of work is essential, as is meticulous attention to detail. The work includes various duties involving different and unrelated processes and methods. The decision regarding what needs to be done depends upon the analysis of the subject, phase, or issues involved in each assignment, and the chosen course of action may have to be selected from many alternatives. Scope and Effect The work involves treating a variety of conventional problems, questions, or situations in conformance with established criteria.
The work product or service affects the design or operation of systems, programs, or equipment; the adequacy of such activities as field investigators, testing operations, or research conclusions; or the social, physical, and economic well-being of persons. Information generated by a research project may have extensive far-reaching applications. Information for decision making and the advancement of health science knowledge both in patient care and the system efficiencies may occur. Personal Contacts The personal contacts are with employees within Research Service, but also include individuals outside the immediate Service such as physicians and clinical staff, research subjects, visitors, and families of veterans.
People contacted may be engaged in different functions, missions, and kinds of work, e.g., representatives from various levels within the agency such as headquarters, regional, district, or field offices, or other operating office in the immediate installation/ Purpose of Contacts The purpose is to gather and synthesize relevant, scientific information from research subjects and health care specialists. The successful incumbent will also plan, coordinate, or advise on work efforts or to resolve operating problems by influencing or motivating individuals or groups who are working toward mutual goals and who have basically cooperative attitudes. Physical Demands The work is primarily sedentary but also requires some standing, walking, bending, lifting and carrying of light items. The work requires above average agility and dexterity.
The work may require heavy lifting of equipment or human subjects. Work Environment The work environment includes everyday risks or discomforts which require normal safety precautions typical of such places as offices, meeting and training rooms, or libraries. The work area is adequately lighted, heated, and ventilated, however, the office is in close proximity to laboratories and animal facilities which require close adherence to facility safety procedures and exposure to animal and autoclaved food and bedding odors. Other Significant Facts Customer Service Meets the needs of customers while supporting missions.
Consistently communicates with and treats customers (veterans, their representatives, visitors, and all staff) in a courteous, tactful, and respectful manner. Provides the customer with consistent information according to established policies and procedures. Handles conflict and problems in dealing with the customer constructively and appropriately. ADP Security Protects printed and electronic files containing sensitive data in accordance with the provisions of the Privacy Act of 1974 and other applicable laws, federal regulations, Protects the data from unauthorized release or from loss, alteration, or unauthorized deletion.
Follows applicable regulations and instructions regarding access to computerized files, release of access codes, etc., as set out in the computer access agreement that the employee signs.