Job Family:Clinical Trial Operations (Digital)

Travel Required:None

Clearance Required:Ability to Obtain NACI

What You Will Do: 

• 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.
• Independently participates in professional development activities to increase knowledge base and performance, including participation in professional organizations. Participates in outside activities that enhance personal and professional growth and development.
• Utilizes enhanced communication skills in team and office activities; uses feedback and other skills to correct and elicit information and change practice in positive ways.
• Observes a wide scope of clinical trials, with ability and willingness to share with others experiences and skills required to build success within the position; translation of needs beyond self to the team and Branch's conduct of clinical trials.
• Participates in workgroups assessing problems impacting the clinical trial process, such as the revision of data collection tools, review of nursing concepts such as quality of life or pain relief, and educational initiatives.
• Performs other duties and responsibilities as assigned.

What You Will Need:

• Minimum of an R.N. degree.
• Licensed as a nurse in any US State.
• Must be able to be credentialed by the NIH Clinical Center.
• Knowledge of environmental safety, including infection control, isolation technique, aseptic technique, and general security.
• Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient’s medical records
• Knowledge of federal regulatory requirements pertaining to clinical research
• Knowledge of Good Clinical Practice (GCP)
• NIH clinical trials experience preferred

What Would Be Nice To Have:

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical, Rx, Dental & Vision Insurance

• Personal and Family Sick Time & Company Paid Holidays

• Parental Leave

• 401(k) Retirement Plan

• Group Term Life and Travel Assistance

• Voluntary Life and AD&D Insurance

• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

• Transit and Parking Commuter Benefits

• Short-Term & Long-Term Disability

• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

• Employee Referral Program

• Corporate Sponsored Events & Community Outreach

• Care.com annual membership

• Employee Assistance Program

• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

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Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.