Overall Position Summary and Objectives:
To provide services and deliverables through performance of support services.
Minimum Qualifications:
- Bachelor's degree in nursing
- 4 years nursing experience
Compensation/Benfits:
- Salary starting at $95,000.00
- Healthcare
- Dental
- Vision
- 401(k)
- PTO
Weekly Hours/Schedule:
- 30-40 hours per week
- Monday-Friday
- No Nights
- No Holidays
Statement of Work Details:
- 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.
- 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.
- Organize and facilitate the training program and teach physicians, physicians in training, nurses and other staff.
- Mentor health care members in the execution of trials and resolution of logistical constraints and update team members of changing directions in study implementation.
- Provide training to clinic staff with regard to Investigator, brochure information, protocol implementation, general and specific data collection and research practices.
- Provide mentorship developing skills and expertise in research protocols and all aspects of clinical research.
- Provide mentorship to nurse specialists to develop skills and expertise in program areas.
- 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.
- Other
- Recruit and follow patients for clinical and basic research studies on HIV vaccines and emerging/re-emerging vaccines.
- 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 risks factors and history of participation in other clinical research.
- Interpret data, responsible for recognizing results that merit prompt clinical action.
- Perform physical assessments of patients, analyzes trends in patient conditions, and suggests possible alterations in treatment regimens according to research protocols.
- Perform protocol activities such as, study drug administration, data collection and submission, patient counseling, and physical assessment.
- Interpret 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.
- Coordinate and ensure the collection of specimens needed for all studies on patients enrolled in vaccine studies
- Maintain contact with patients and referring physicians to explain patient’s conditions and symptoms, interprets results of laboratory tests; discusses the future status of patients who have participated in the study.
- Follow up on patients throughout study to schedule procedures, follow-up examination, transportation and admissions.
- Counsel patients regarding the potential risks of clinical research and obtains informed consent.
- Provide competent HIV Testing Counseling, and on occasion, deliver HIV Positive results in case of a new HIV Infection.
- Participate in recruitment and outreach activities contributes to recruitment strategies through innovative ideas.
- Participate and coordinate protocol training and mentor new staff.
- Enter/extract patient information to generate reports.
