Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Institute of Diabetes and Digestive and Kidney Diseases. The primary objective is to provide services and deliverables through performance of support services.
-
Organize and facilitate the training program and teach physicians, physicians in training, nurses and other staff. – 1
-
Mentor health care members in the execution of trials and resolution of logistical constraints and update team members of changing directions in study implementation. – 2
-
Provide training to clinic staff with regard to Investigator, brochure information, protocol implementation, general and specific data collection and research practices. – 3
-
Provide mentorship developing skills and expertise in research protocols and all aspects of clinical research. – 4
-
Provide mentorship to nurse specialists to develop skills and expertise in program areas. – 5
-
Recruits and screens patients for inclusion in protocols and clinical trials.
-
Assist research and medical staff interview, screen and evaluate the appropriateness of eligible subjects for participation in the research protocol.
-
Participate in recruitment and outreach activities and contribute to recruitment strategies through innovative ideas.
-
Recruit and follow up with patients for clinical and basic research studies and protocols and provide clinical support to patients participating in protocol.
-
Design and maintain a selection of materials appropriate to send to health care referral sources seeking eligibility information or other objectives.
-
Organize and maintain an active referral list and master schedule for planning follow up and new patient admissions.
-
Provide instruction to potential clinical study subjects and those involved in care of subjects on aspects of subject’s care, treatments, and side-effects.
-
Provide information about the study to referring physicians, advocacy groups, NIH offices, and in response to inquiries from potential study participants.
-
Performs assessments and physicals and collects medical histories.
-
Participate in direct patient care, in coordination with interdisciplinary team and specific team members to create and communicate a plan of care that balances clinical care needs with research.
-
Obtain and record complete health histories and conduct physical assessments; communicate data from these and other sources.
-
Manage clinical and research support activities to ensure patient safety and address the clinical needs of the patients.
-
Review findings from assessments and other sources in clinical rounds.
-
Review charts to collect relevant clinical data such as laboratory test results and social background.
-
Complete medical and psychiatric assessments of potential participants in multiple research protocols by collecting and reviewing past and present medical records and conduct interviews with research applicants and their families.
-
Conduct family interviews to obtain comprehensive understanding of the care needs of the patient.
-
Continually assess ongoing understanding of the research process for patients and families and provide teaching and support as indicated.
-
Administers protocol consents and documentation and monitors compliance.
-
Ensure informed consent process and human subjects protection in clinical research and counsel patients regarding the potential risks.
-
Collaborate with researchers and medical staff to obtain and maintain informed consent and assent and address ethical and legal implication of the research protocol.
-
Contribute to all study related IRB and regulatory matters, including all reporting requirements (including deviations, unanticipated problems, adverse events) and report issues and variance promptly to the research team.
-
Collect and report data to appropriate regulatory and monitoring agencies.
-
Perform quality assurance and quality control activities relating to protocol adherence, protocol monitoring, data collection, data abstraction and data analysis and protect research participant data in accordance with regulatory requirements.
-
Coordinate various activities to ensure proper and filing of serious adverse events, amendments, annual reports, and other regulatory documents.
-
Prepare documentation and track and report regulatory and institutional protocol requirements and resolve all stipulations from protocol oversight groups.
-
Performs data input and management.
-
Perform accurate data entry into research database, including the use of standardized scales and assessments.
-
Participate in data analysis and management as well as manuscript preparation and presentation of findings.
-
Maintain computerized patient files and databases containing research data generated through protocol studies and perform data searches of medical records for analyses of patient characteristics.
-
Support the general implementation, tracking, data acquisition, collection and reporting of all elements of the protocols.
-
Manage data through research databases to ensure accurate and reliable data entry.
-
Examine and monitor patients during protocol studies; ensure the collection of a complete clinical database on each patient.
-
Provide expertise in clinical trial coordination and management of data acquisition.
-
Performs clinical data interpretation and evaluates and interprets protocol and clinical trial findings.
-
Document observations and identify and evaluate trends and important findings, communicating information to the multidisciplinary research team for prompt clinical action.
-
Monitor activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials.
-
Present clinical data in terms which may be understood by the patient, as well as, interpretation at a level which is conversant with other health professional including physicians.
-
Develop intake tools and screening forms and work with researchers and medical staff on the general administration of protocols’ implementation.
-
Collaborate with staff to analyze and evaluate current systems of health care delivery and to identify and implement new practice patterns.
-
Participate in clinical practice and research support meetings and develop multidisciplinary performance improvement programs and projects to improve operating procedures, patient care and decrease costs.
-
Problem-solve complex or unpredictable situations and improve processes and services to patients and colleagues. Participates in training and mentoring new staff.
-
Develops new research protocols.
-
Participate in the design and implementation of current and future protocols and studies.
-
Survey the medical literature for background information on specific aspects of the diseases under purview.
-
Design, implement and evaluate complex protocols and manage challenging patient populations and assist with document preparations and processes.
-
Develop new standards for novel and unpredicted research situations and interventions.
-
Utilize established resources to design new study methods to meet research study objectives.
-
Work with staff on drafting of new protocol amendments and associated documents by providing editorial support and expert opinion.
-
Perform protocol activities including study drug administration, data collection and submission, patient counseling and physical assessment.
-
Maintain contact with patients and referring physicians to explain patient’s conditions and symptoms; interpret results of laboratory tests; discuss the future status of patients who have participated in the study.
-
Interface with the inpatient and outpatient unit staffs to assess patient concerns and facilitate compliance with protocol studies.
-
Examine and monitor patients during protocol studies; ensure the collection of a complete clinical database on each patient.
-
Ensure that protocol and regulatory requirements are met in terms of patient safety and research goals.
-
Participate in scheduled clinical update lectures at the LDB, branch meetings, clinical grand rounds and various relevant lectures.
-
Respond to telephone inquiries from protocol patients regarding management problems; answer questions regarding patient medications, disease processes or health-related matters.
-
Provide counseling and teaching for patients and their families as appropriate; direct inquiries to section chiefs or medical staff fellows if additional action is necessary.
-
Act as liaison with Clinical Center nursing staff and the fellows/clinical associates in the Hepatology Training program.
-
Perform preliminary review of patient referral and inquiries; obtain additional clinical and/or historical information as necessary based on research protocol criteria; direct information to the attending physician for action; work with physicians in writing letters to communicate with patients.
-
Determine appropriate diagnostic testing in conjunction with medical staff.
-
Stay abreast of the current therapeutics and clinical practices for patients with liver disease.
-
Gather data for yearly IRB reviews; coordinate the submission process.
-
Work with staff on prescheduling the appropriate evaluations, arranging patient travel and providing the patient with written confirmation of the appointment time and a list of the scheduled diagnostic testing.
-
Schedule appropriate medical consultations as necessary.
-
Participate in the weekly patient care conference; assemble diagnostic studies (x-rays and scans) for review at the conference.
-
Attend professional meetings and seminars.
-
Review and summarize relevant literature.
-
Identify and implement ways to improve operating procedures, patient care and decrease costs.
-
Work with staff on the recruitment and retention of patients into specific clinical protocols; ensure protocol compliance and database management.
-
Implement clinical protocols.
-
Educate patients regarding the nature of the disease process and possible therapeutic strategies and protocol objectives.
-
Review charts to collect relevant clinical data such as laboratory test results and social background.
-
Interview patients to obtain medical history, sexual history, medication history, history of use of substances such as alcohol and recreational drugs, previous HIV-related risk factors and history of participation in other clinical trials.
-
Identify potential problems that may impede protocol implementation; determine if these problems need to be referred to the principal investigator for action or can be dealt with independently.
-
Examine protocols regarding nursing support requirements and patient safety matters.
-
Maintain computerized patient files and databases containing research data generated through protocol studies.
-
Interpret data; identify results that merit prompt clinical action.
-
Maintain required documentation and files for research protocols.
-
Perform physical assessments of patients; analyze trends in patient conditions; suggest possible alterations in treatment regimens according to research protocols.
