Research Nurse
Company: Guidehouse
Location: Bethesda
Posted on: May 26, 2023
Job Description:
Job Family:
Clinical Trial Operations (Digital)
Travel Required:
None
Clearance Required:
Ability to Obtain Public Trust
- Assists in developing clinical research and protocol-specific
standards of practice (SOP).
- Develops, implements, and assesses process improvement
strategies for compliance with applicable regulations and
SOPs.
- Develops and institutes a nursing feasibility review process to
assess the ability to implement the protocol trial within local
nursing care practices and standards.
- Develops methods to overcome institutional and external
barriers to protocol compliance.
- Collaborates with the principal investigator to finalize,
ensure implementation, assess efficacy, and revise corrective and
preventive action plans.
- Participates in the preparation of reports for appropriate
regulatory agencies and monitoring bodies or boards.
- Collaborates with PIs to resolve protocol implementation
problems during design period; uses and revises/creates data
capture forms to meet study needs.
- Directs the activities of multiple personnel involved in trials
through clear delineation of responsibilities, endpoints, and
approaches based on scope of practice and/or training.
- Assures compliance of clinical trial objectives and
endpoints.
- Collaborates with health care members in the execution and
management of trials; communicates findings and suggestions to the
PI based on expertise; reports clinical data to regulator and
monitoring agencies; produces reports for clinical use and
treatment decision-making; and summarizes clinical data as
requested by PIs.
- Continuously assesses and reports situations that can lead to
research misconduct.
- Works with principal investigators (PIs) and/or research
programs to develop and implement interventions to provide
education about misconduct to mitigate risk.
- Works with PIs and/or research programs to develop and
reinforce a culture that facilitates compliance with reporting
research misconduct.
- Develops, implements, and evaluates processes to address
institutional barriers to effective ongoing informed consent.
- Develops supplemental materials for institutional review board
(IRB) approval that assist in the informed consent process.
- Develops and enacts comprehensive processes to ensure
compliance with re-consenting needs.
- Collaborates with PIs to utilize appropriate consent format and
content.
- Ensures compliance with consent for correlative studies by
tracking the patient's wishes related to collection of associated
specimens or data.
- Supports the informed consent process by continually providing
patient/family counseling related to clinical trials and to the
clinical trials process.
- Identifies trends, facilitators, and barriers in recruitment
and retention.
- Develops, implements, and assesses interventions to overcome
identified recruitment and retention challenges. Detects
inconsistencies and required improvements in eligibility procedures
used within teams.
- Collaborates with PIs to revise eligibility criteria or change
team processes according to protocol. Identifies problems in
referral process and implements strategies to handle problems.
- Develops recruitment and retention plans. Assists the PI and
sub-investigators in the effective coordination of recruitment and
retention efforts.
- Evaluates and determines resources required to implement
recruitment and retention plans.
- Consistently recognizes physician investigators and research
staff for recruitment and retention efforts.
- Chooses from materials appropriate to send to health care
referral sources seeking eligibility information.
- Develops materials with input of PIs and IRB approval.
- Displays strong collaborative skills in efforts to improve
sensitivity to multicultural and ethnic influences on patient's
ability to enroll in and complete clinical trials.
- Interviews and evaluates all patients being screened for entry
into clinical trials.
- Develops study-specific materials for patient education and
ensures IRB and sponsor approval, as required.
- Ensures protocol clarity in treatment modification
guidelines.
- Assesses for and addresses trends that affect patient adherence
to protocol-specific activities.
- Develops, implements, and assesses necessary interventions to
address issues related to the patient population on a clinical
trial.
- Interacts with physicians and web-based referral sources to
assure that physicians and/or patients and their families receive
answers to their questions and appropriate referral information in
a timely manner.
- Collaborates with the interdisciplinary team to develop nursing
practices that have the potential to improve patient outcomes.
- Provides guidance to participating sites related to patient
management per protocol trial requirements. Facilitates accurate
communication between research sites.
- Assesses for and addresses changes that increase the acuity of
assigned protocol trials and that adversely affect protocol
management abilities.
- Identifies and implements workload assessment tools and
processes to ensure patient safety and data integrity.
- Assures timely scheduling of patients for appointments/testing
and careful acquisition and distribution of clinical samples.
- Assures that all protocol required testing has been scheduled
and patient visits are scheduled in accordance with protocol
guidelines.
- Maintains involvement in all aspects of the clinical trial
process.
- Conducts updates for patient care areas on protocol process and
progress, and events impacting clinical care and data
collection.
- Coordinates care for study participants. Care requirements are
determined by the scope of the study participation and clinical
conditions of the patient and the clinical effects on research
procedures.
- Collaborates with study investigators and interdisciplinary
care teams to identify opportunities to improve care and outcomes
for patients participating in research studies.
- Provides expert consultation in matters related to the research
process and specific, complex patient populations.
- Monitors the research participant for adverse events and
reports to the study PI. Investigates the etiology of discrepancies
or unusual sentinel events and provides feedback and
recommendations for resolution and problem prevention.
- Adjusts research priorities based on research participant's
changing needs.
- Participates in the development of approved source documents,
templates, or forms.
- Participates in all office and branch activities to improve
documentation.
- Implements plans to address identified trends related to
noncompliance or deficiencies with source documents.
- Participates in the preparation of reports for appropriate
regulatory agencies and monitoring bodies or boards.
- Assists the principal investigator in developing data
management plans for each clinical trial.
- Uses information management and computer technology to support
clinical data management activities.
- Assists in developing case reporting forms (CRFs) for multisite
clinical trials.
- Participates in Quality Improvement and Quality Assurance
(QA/QI) initiatives at the Section level; database and data system
development efforts to produce consistency; and standardization and
application of professional standards for gathering, storage,
entry, reporting, and analysis of clinical trials data.
- Participates in ORSC-wide review of quality assurance/quality
improvement and data entry procedures; direction of data management
staff; and data entry and report generation activities designed to
revise, plan, or upgrade data entry procedures.
- Anticipates and consistently meets reporting deadlines,
collaborating with PIs and teams to note data trends and identify
problems. Notes trends in toxicities, patient information, and data
collection points.
- Participates in and directs organizational audits performed by
sponsor and/or regulatory agencies.
- Assists patients in identifying the financial impact of the
study on them and makes appropriate referrals.
- Verifies that routine care versus research-related cost
descriptions in the protocol document match the consent document
and vice versa. Ensures that the informed consent document
identifies that stipends to patients for protocol-related
activities are disclosed.
- Pursues opportunities to participate in local or national
research-related activities (e.g., professional nursing and/or
research organizations, institutional committees).
- Provides mentorship to new clinical trials nurses, research
team members, and other healthcare providers.
- Advocates for clinical trials by participating in community
outreach efforts to provide general clinical trials education when
opportunities arise.
- Disseminates information about the impact of new treatments and
nursing practice. Participates in the development of publications
related to clinical trials with focus on patient management and
impact on current or future nursing practice.
- Participates in the use of professional continuing education
programs or may teach programs/classes focused on maintaining and
enhancing the skills required for the position.
- Maintains inventory of patient teaching tools, calendars,
diaries, etc. Participates in the review and evaluation of
education materials, journal articles, and reading materials for
patients and professional development programs. . click apply for
full job details
Keywords: Guidehouse, Bethesda , Research Nurse, Healthcare , Bethesda, Maryland
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