Assistant, Clinical Trials - Center for Health Research
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Provides clinical research support for studies involving human subjects including administration; project implementation, meeting support, quality assurance, budget management, and dissemination of results, recruitment; collection, recording, and editing of interview, questionnaire, and clinical data; performing quality assurance monitoring of study data; randomization of study participants; conducting case management tasks; scheduling participant appointments; supporting clinical and group intervention; review medical records following study protocols; and performing other duties in support of clinical trials services as assigned. Practice in a manner that promotes participant satisfaction and advances the departments purpose, mission, vision, and values. Percentage of time allocated to major accountabilities varies significantly depending on stage of the projects on which the individual is working at any given moment.
- Recruit study participants to a broad range of studies using specific study protocols to contact, screen, and determine eligibility and schedule appointments with study participants. Use standard assessment instruments. Record appointments in Patient Appointment System (PAS). Use tracking systems to record recruitment, assessment, and other study events. Use appropriate computer programs to assist in participant identification; data collection; tracking; ordering referrals, laboratory tests or procedures; or communication, such as RRS, Health Connect, study specific programs, PAS, and other computer software as needed.
- Support coordination of protocol development. Understand the initial project plan and changes as they pertain to CHR/ KP departments, other institutions, and the project- coordinating center. Understand and provide support and assistance in the development of research project timeline, procedures, forms, scripts, manuals, and tracking systems. Provide assistance in the administrative, technical, and scientific day-to-day operation of the study to assure project goals and timelines are met, quality data is collected and managed, and to assure participant and/or data confidentiality. Participate as a member of the project and provide assistance and support for regional and national project meetings and conference calls.
- Collect, edit and record/enter study data via interview, structured interview, questionnaire, medical record review, and basic clinical measurements following 2 to 3 (up to 5 for abstraction) complex study protocols, and perform technical duties as assigned: In accordance with technical training, conduct interviews to collect study data (screening and follow-up visits) per research protocols. Collect, record, and edit data on data collection forms. Participate in procedures for assessing quality control. Reviewing on-line and chart based medical and dental records to interpret, abstract data, and as necessary, code data.
- Support and assist more senior project managers, research associates, clinic coordinators, and/or PIs in the coordination of hiring of project staff. Provide assistance and support for all project meetings and conference calls.
- Support the development of quality assurance procedures, and assist with the monitoring of data collection, and data transfers in accordance with CHR policies and procedure. Understand the importance of protections implemented for research participants.
- Support orientation and structured intervention sessions in accordance with technical training and certification(s): Collect weights, food records, interview data, and other measures at group intervention sessions in accordance with research protocols; Set up and tear down group intervention rooms; As training and certifications allow, complete, edit and enter dietary assessment data collection forms (diet recalls, food records, frequencies, and diaries), including assessing quality control. Provide individual support and encouragement to study participants.
- Support the project manager, RA, clinic coordinator, or PI in the administration of the grant/contract per federal rules and regulations and/or specific grant/contract language. Understand the operational budget and sub-contracts; track documentation and authorization of payment of study related bills. Interact with CHR finance department to track budget and reporting compliance. Support the coordination of the development of the continuation budget. Support the development of new proposal budgets. Provide assistance in the preparation of project reports for PI review and approval.
- Assist with case management activities to support the work of the project/s: Enter participant information into a data base using the case management software, including such variables as demographics, class attendance, points of service, eligibility criteria and other relevant information. Assist study staff in conducting orientation and intervention sessions. Perform retention activities including Motivational Interviewing during screening, calling participants to follow up on missed attendance, rescheduling appointments, monitoring tracking systems for study tasks, participate in retention case management meetings with study staff.
- Support the process of summarizing and sharing project information with other sites. Support senior project manager, research associate, clinic coordinator, and/or PI in the maintaining regular contact with other project administrators to share information and ideas. Assist with the tracking of papers in process for projects, with planning for project papers and posters to be presented at national and international conferences. Perform other duties as assigned.
- Minimum two (2) years of experience collecting information using one of the following methods: telephone/face-to-face interviews, working with patients and study participants in clinical situation, medical record abstraction.
- Minimum one (1) year of experience collecting or processing data for research or quality assurance purposes.
- High School Diploma or General Education Development (GED) required.
- Basic Life Support within 1 months of hire
- Working knowledge of medical terminology, anatomy, and disease processes; medical record organization and interpretation.
- Demonstrated interpersonal, communication, and interviewing skills with people of all ages.
- Organized, detail oriented, self-directed, and dependable.
- Able to prioritize work, solve problems, and work independently.
- Able to function in a team environment and use negotiation skills.
- Phlebotomy experience.
- Laboratory processing experience.
- Fluent in Spanish.
- Knowledge of basic research ethics and principles.
- Skilled in working with personal computers.
- Experience in health research or research data collection.
- Familiarity with classification of disease processes (diseases, symptoms, procedure, lab/x-ray test, drugs, and episodic relationships.
- Demonstrating aptitude in the other two areas: telephone/face-to-face interviews, working with patients and study participants in clinical situation, medical record abstraction.
- Associates degree or extensive college courses in social sciences or related field.
- Will work some Saturdays.