Clinical Research Coordinator I

DescriptionGENERAL SUMMARY/ OVERVIEW STATEMENT:A full-time clinical research coordinator reporting directly to Dr. H. Diana Rosas is needed in MIND clinical translational research program/Center for Neuroimaging of Aging and Neurodegenerative diseases, to work in a multidisciplinary group conducting clinical studies of aging, cognition, and neuroimaging in adults with Down syndrome at risk for Alzheimer disease and/or in Huntington’s disease. The incumbent is expected to work both independently and as a team member with other members of the team including investigators, staff, post-doctoral fellows, and students. The primary responsibilities of the Clinical Research Coordinator will be to manage clinical, basic science, and technology research studies within the laboratory. Working independently under the PI, he or she will be responsible for pre-screening of healthy volunteers and patients, scheduling and recruitment, evaluating study participants, as well as administrative duties related to the careful operation of the study protocol. He or she will assist in spreadsheet management, including maintaining appropriate protocols for data security, access and quality assurance. He or she will also assist with the coordination of the study, including recruiting and scheduling participants, and the basic setup and acquisition of the experimental sessions in the MRI scanner, including helping setup physiological recording devices, and will help situate and/or accompany and/or conduct scanning (as needed) of the volunteers. He or she will work independently under general direction of the PI to coordinate research studies as well as to fill a limited supervisory role in the laboratory. He or she will coordinate regulatory and compliance activities and monitor laboratory safety. He or she will work with research staff to coordinate all laboratory activities including administrative tasks, study visits, and data analysis to assure that the laboratory is meeting the general goals and commitments of the PI. This effort will be in the form of weekly meetings with the PI, organizing and setting the agenda for weekly group laboratory meetings.PRINCIPAL DUTIES AND RESPONSIBILITIES:Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position. Follows procedures laid out by the lab standard operating procedures. Has active and thorough knowledge of all SOPs and executes then as standardized.Assists with recruiting and retaining participants/patients for both observational and for clinical trialsWorks closely with study subjects, including patient/caregiver interviews, neuropsychological testing, assistance with obtaining vital signs, EGKs, brain imaging (which may include accompanying participants into the MRI/PET scanner for the duration of the study), and phlebotomy -may involve occasional home visitsProcesses biological samples, ensures appropriate processing, labeling and storage, maintains accurate sample databaseDocuments and compiles clinical research data, schedules appointments and procedures, and maintains study databasesMeets regularly with Principal Investigator(s) to discuss assignments, projects and administrative matters; keeps them informed relative to status of sameAttends training courses as identified/needed; maintains certificationsOrganizes, analyzes, and summarizes acquired data, using scientific and statistical techniquesPrepares and presents reports for meetings, grants, manuscriptsOrganizes and/or drafts material for the preparation of research papers, manuscripts, or other documents for publication and/or presentation as appropriateCollects & organizes patient/participant dataMaintains accurate and timely records and databasesUses software programs to generate graphs and reportsObtains participant/patient study data from medical records, etc.Conducts library searchesVerifies accuracy of study formsUpdates study forms per protocol; maintains accurate log of up to date formsDocuments participant/patient visits and proceduresAssists with the preparation and maintenance of regulatory binders and QA/QC proceduresAssists with interviewing study subjects/patientsAdministers and scores questionnaires/cognitive assessmentsProvides basic explanation of study and in some cases obtains informed consent from subjectsAssists with study regulatory submissions, including new and continuing studiesWrites consent formsVerifies subject inclusion/exclusion criteriaPerforms administrative support duties as requiredPrepares for monitoring visits/responding to queries from monitoring visitPerforms administrative support duties as required.Collects & organizes participant/patient data, both clinical and studyMaintains records and databasesUses software programs to generate graphs and reportsObtains patient study data from medical records, physicians, etc.Conducts library searchesVerifies accuracy of study forms and assists in monitoring other lab studiesUpdates study forms per protocolDocuments participant patient visits and procedures accurately and thoroughlyAssists with interviewing study subjects/patientsAdministers and scores questionnairesAdministers and scores cognitive testsProvides basic explanation of study and in some cases obtains informed consent from subjectsPerforms study procedures, which may include phlebotomy/EKG/Blood processing.Assists with study regulatory submissionsVerifies subject inclusion/exclusion criteriaHelps train new staffA Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:Maintain research data, patient fields, regulatory binders and study databasesPerform data analysis and QA/QC data checksOrganize and interpret dataDevelop and implement recruitment strategiesAct as a study resource for patient and familyMonitor and evaluation lab and procedure dataEvaluate study questionnairesContribute to protocol recommendationsAssist with preparation of annual reviewMay assist PI to prepare complete study reports Works independently to conduct study visits; has supervisory role over new CRC’sQualificationsSKILLS/ABILITIES/COMPETENCIES REQUIRED: Careful attention to detailsStrong Interpersonal skillsExcellent organizational skillsSolid Mac or PC computer skillsAbility to follow directions and ability to work both independently and as part of a teamExcellent communication skillsComputer literacyWorking knowledge of clinical research protocols; understanding of Good Clinical PracticeAbility to demonstrate respect and professionalism for subjects’ rights and individual needsAbility to effectively multitask, prioritize multiple projects and handle fluctuating priorities and deadlines FlexibilityAbility to ask for help when neededThe Clinical Research Coordinator II should also possess:Ability to work independently and as a team playerAnalytical skills and ability to resolve technical problemsAbility to interpret acceptability of data resultsWorking knowledge of data management programEDUCATION: Bachelor’s degree required. Field of study/additional specialized training: neuroscience, psychology, or premedical science desirable.EXPERIENCE: New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above. Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position. SUPERVISORY RESPONSIBILITY (if applicable): A Clinical Research Coordinator I does not have any supervisory responsibility. A Clinical Research Coordinator II may assist with the training and orientation of new staff members.Job Field: ClinicalOrganization: Massachusetts General Hospital(MGH)Schedule: Full-timeShift: Day JobEmployee Status: Regular