Clinical Trials Study Coordinator
We are currently searching for a Clinical Trials Study 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
- Provides advanced expertise in clinical protocol coordination and implementation, data and protocol management. Oversees the implementation, tracking, data abstraction and collection, data reporting, and coordination of a variety of protocols in affiliation with the program.
- Performs ongoing quality improvement and quality control assessments to monitor protocol progress for participants
- Develops standard operating procedures to streamline processes in order to increase effectiveness of procedures and prevent error
- Uses problem solving skills to troubleshoot protocol and sequencing issues
- Analyzes and manages data using a variety of systems, including Laboratory Information Management Systems (LIMS), Microsoft Excel, statistical analysis software such as R or SPSS and programming languages such as Python.
- Learns new systems thoroughly as needed and adapts quickly to new procedures in order to meet the needs of program operations
- Communicates effectively using oral and written methods with a multidisciplinary team of clinicians, researchers, genomics service providers, geneticists, bioinformaticians, trainees, laboratory technicians, and others involved in operations.
- Provides informed consent for patients for the Centralized Sequencing Protocol (CSP)
- Ensures that families of participants are properly consented and understand implications of genetic research.
- Screens patients, obtains medical history, and acquires outside medical records and pathology specimens, while addressing complex ethical and legal implications; Educates families on basic concepts of genetics as it relates to their illness, and establishes rapport and works with families under stress, provides emotional support and refers to appropriate resources.
- Documents informed consent in CRIS and CRIMSON patient medical information systems.
- Uses sound judgment and clinical expertise to adjust patients' plans of care in the absence of established guidelines.
- Manages protocols relating to human subjects’ research and the collection and processing of human samples procured under the auspices of NIH-approved clinical research protocols.
- Thorough and comprehensive knowledge of the purpose and function of IRBs and regulations governing IRBs, including 45 CFR part 46 and 21 CFR part 56. Thorough knowledge of NIH IRB standard operating procedures, and other policies regarding IRB review and human subject research safety.
- Maintains strict compliance with IRB, NIH and Federal Regulations governing human subjects’ research.
- Performs, and/or coordinates the collection, processing and handling of laboratory samples including appropriate storage and shipping.
- Places orders for sample collection and/or on extracted DNA samples for sequencing, as well as orders for additional testing, such as Sanger sequencing
- Coordinates the procurement of samples from referring physicians worldwide to further program research.
- Works with purchasing agents, contract officers, and vendors on procurement of materials, supplies, and genomics services
- Participates in clinical practice and research support peer review and develops multidisciplinary performance improvement programs and projects. Maintains an overview of the clinical program in order to collaborate and contributes to planning and resource allocation. \
- Assists in preparing and analyzing clinical and genetic data for publication in biomedical journals.
- Conducts educational presentations to nursing units, clinics and other departments referring patients to the program.
- Ensures compliance with training for protection of human subjects, conflict of interest guidelines, and patient confidentiality. Ensures accurate and timely entry of data to bio-specimen databases.
- Maintains integrity of databases by conducting periodic audits and reports to project leads.
- Creatively solves problems related to obtaining viable patient samples from international locations and from patients with limited resources.
- Directs and performs 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.
- Pursues activities to facilitate the ease of reporting, avoidance of repetition of data entry procedures, and generation of reports.
- Analyzes data, notes trends and implications of same, publishes and presents finding locally, nationally, and internationally representing the program.
- Serves 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.
- Uses advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues.
- Writes expert documents relevant to research, clinical care and related subjects including published works and executive reports.
- Acts as a mentor to students, IRTA fellows, and nurse specialists/practitioners new to the NIH environment. Provides formal education to others in the field of expertise including lecturing at colleges and continuing education programs.
- Collaborates with peers and other multidisciplinary team members to analyze and evaluate current systems of genomic medicine and to identify and implement new practice patterns as appropriate.
- Engages in self-directed learning and reading of literature to obtain in depth knowledge about genomics
- Participates in outside activities that enhance personal and professional growth and development.
- Bachelor’s degree in a related field required. Master’s degree preferred in Public Health (MPH), Biostatistics, or Statistics, or Genetic Counseling highly preferred.
- Nurse Practitioners and Physician Assistants with applicable experience and current licensure and/or certification to practice in the state of Maryland are also welcome to apply.
- Minimum of four (4) years in a clinical environment.
- NIH clinical trials experience highly desirable, but not required.
- Experience using NIH clinical systems such as CRIS and Crimson highly desirable.
- Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient’s medical records.
- Excellent interpersonal skills.
- Organized and detail oriented.
- Research/clinical background a must.
Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.Company Description
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.