Job Family :

　　Nurse Practitioner (Digital)

　　Travel Required :

　　Up to 10%

　　Clearance Required :

　　Ability to Obtain Public Trust

　　What You Will Do :

　　Provide advanced expertise in clinical trial coordination and implementation, data and protocol management. Oversee the implementation, tracking, data abstraction and collection, data reporting, and coordination of a variety of clinical trials in affiliation with the program.

　　Interview, screen and recruit patients for entry onto protocols.

　　Ensure that families of participants are properly consented and understand implications of research. Screen patients, obtain medical history, and acquire outside medical records and pathology specimens, while addressing complex ethical and legal implications.

　　Perform, and/or coordinate the collection, processing and handling of laboratory samples including appropriate storage and shipping.

　　Coordinate the procurement of samples from referring physicians worldwide to further the laboratory's research.

　　Monitor response to therapy and adjust plan of care per protocol specifications, standards of practice, and other guidelines.

　　Use sound judgment and clinical expertise to adjust patients' plans of care in the absence of established guidelines.

　　Manage protocols relating to human subject’s research and the collection and processing of human samples procured under the auspices of clinical research protocols.

　　Work to maintain protocol and office files, databases, and records. Provide administrative and technical guidance to investigators and institute staff.

　　Maintain strict compliance with regulations governing human subject’s research.

　　Prepare reports and respond to outside inquiries and audits from program oversight and regulatory offices.

　　Educate investigators and staff and assure that all policies and procedures are disseminated to supervisors and other appropriate program staff via written and electronic communication.

　　Provide training to clinic staff with regard to Investigator Brochure information, protocol implementation, general and specific data collection and research practices.

　　Direct health care members in the execution of trials and resolution of logistical constraints and assures all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met or exceeded.

　　Educate families on basic concepts of the human immune system and hereditary disease as it relates to their illness.

　　Process and guide research protocols through the review cycle of submission, initial review, continuing review, amendments, and reporting. Obtain translations of protocol consents into various languages and updates translated consents as needed. Arrange for translators in advance of protocol visits.

　　Ensure compliance with training for protection of human subjects, conflict of interest guidelines, and patient confidentiality. Ensure accurate and timely entry of data to bio-specimen databases.

　　Direct and perform quality assurance and quality control activities as they relate to protocol adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety.

　　Report data to appropriate regulatory and monitoring agencies. Anticipate and create database/case reports to meet protocol needs. Translate data collection needs into clinic wide standards and tools, collaborating with resources beyond the intramural setting to maintain data collection tools.

　　Pursue activities to facilitate the ease of reporting, avoidance of repetition of data entry procedures, and generation of reports appropriate to various agencies.

　　Design and maintain a selection of material appropriate to send to health care referral sources seeking eligibility information or for other appropriate objectives.

　　Analyze data, note trends and implications of same, publishes and presents finding locally, nationally and internationally representing the program.

　　Serve in formal or informal leadership positions and is recognized as an expert in a clinical or research specialty area. Serve as a consultant and role model for professional practice, collaboration and communication.

　　Use advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues.

　　Participate in clinical practice and research support peer review and develops multidisciplinary performance improvement programs and projects. Maintain an overview of the clinical program in order to collaborate and contributes to planning and resource allocation.

　　Collaborate with peers and other multidisciplinary team members to analyze and evaluate current systems of health care delivery and to identify and implement new practice patterns as appropriate. Participate in outside activities that enhance personal and professional growth and development.

　　What You Will Need :

　　Must have BSN or MSN degree, and a valid Nursing license.

　　Minimum of three (3) years direct experience in a clinical or patient care environment.

　　Knowledge of the basics of the clinical trial process desired.

　　Experience collecting and organizing data for reporting and maintaining patient records.

　　Exceptional interpersonal skills and communication skills, both oral and written.

　　Strong organizational skills. Able to work independently or as part of a team.

　　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.

　　If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [email protected] . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

　　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.