We are currently searching for a Clinical Research Coordinator to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.
Duties & Responsibilities
- 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 genetic 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 adjusts 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.
- Document informed consents in CRIS and CRIMSON patient medical information systems.
- Manage protocols relating to human subject’s research and the collection and processing of human samples procured under the auspices of NIH-approved clinical research protocols.
- Work to maintain NIH protocol and office files, databases, and records. Provide administrative and technical guidance to investigators and institute staff on NIH functions.
- Maintain strict compliance with NIH and Federal Regulations governing human subject’s research.
- Stay current with NIH requirements. Prepare reports and respond to outside inquiries and audits from program oversight and regulatory offices.
- Educate investigators and staff and assures that all NIH 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.
- Establish rapport and works with families under stress, provide emotional support and refers to appropriate resources.
- 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.
- Assist in preparing and analyzing clinical data for publication in biomedical journals.
- Serve as a primary contact point for the Laboratory for protocol procedures and regulations.
- Provide administrative and technical guidance for new investigators.
- Conduct educational presentations to nursing units, clinics and other departments collaborating on clinical trials.
- 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.
- Maintain integrity of databases by conducting periodic audits and reports to Laboratory Chief.
- Provide advice and expertise to technicians on maintaining Clinical Laboratory Improvement Amendment (CLIA) certification for the Laboratory where appropriate and participates in CLIA inspections.
- Serve as a primary contact point for the Laboratory in regard to protocol procedures, regulations and requirements. Serves as the liaison between various individuals and offices involved in the oversight of human subject’s research at the NIH.
- Serve as the liaison between Laboratory and other teams, clinical nursing staff, Clinical Center Staff, other institutes and centers of the NIH, extramural collaborators, referring physicians, patients and their families.
- Participate in the development and maintenance of hard copy and electronic systems to prepare, monitor and track protocols and submissions. Participate in the development and maintenance of systems used to manage databases and to monitor compliance with applicable regulations. Maintain files and records on all protocols for the required periods of time.
- Creatively solve problems related to obtaining viable patient samples from international locations and from patients with limited resources.
- Collaborate with many of the following professionals and/or organizations: pharmacy, laboratories, pharmaceutical agencies/sponsors and monitors, Contract Research Organizations, the Food and Drug Administration, and the Institutional Review boards and IND holders.
- 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. Anticipates and creates 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. Serves 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.
- Write expert documents relevant to research, clinical care and related subjects including published works and executive reports.
- Act as a mentor to students and nurse specialists/practitioners new to the program environment. Provide formal education to others in the field of expertise including lecturing at colleges and continuing education programs.
- 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.
- Must have BSN or MSN degree, and a valid Nursing license.
- Minimum 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.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.
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 accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. 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.