Clinical Research Coordinator I - General Internal Medicine (Bilingual or Spanish-Speaking appl[...]

Bilingual or Spanish-speaking applicants strongly encouraged to apply (not required for consideration). Clinical Research Coordinator I/II Job Profile Summary This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. The role includes supporting new product development, clinical research projects, and translational research to solve specific problems for an entity or community. The position is an entry‑level professional contributor role that may direct the work of lower‑level professionals or manage processes and programs, spending most of the time overseeing the design, implementation, and delivery of processes, programs, and policies using specialized knowledge typically acquired through advanced education. Job Overview This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. Minimum Qualifications Bachelor’s degree or high school diploma or equivalent and four (4) years of related experience. Basic Life Support (BLS) certification may be required based on specific role requirements. Preferred Qualifications Two (2) years in research-related activities. IATA Hazardous Good Shipping certification. CITI Human Research Protection certification. Duties and Responsibilities Assist in the recruitment of study participants. Complete follow‑up with study participants in prescribed settings as required. Abstract source documents, conduct required study measurements, and complete study Case Report Forms in accordance with best practice methods. Comply with all institutional policies and government regulations pertaining to human subjects protections, maintain regulatory binders, case report forms, source documents, and other study documents. Monitor occurrence of clinical adverse events, reporting any to the PI, study sponsor, and Institutional Review Board. Assist with Institutional Review Board (IRB) requirements for each study, including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews. Perform basic laboratory activities as needed. Maintain patient confidentiality per HIPAA regulations and keep study information in a safe and secure location. Adhere to FDA Good Clinical Practice Guidelines. Identify and resolve protocol compliance problems by notifying investigator and, if necessary, with the protocol sponsor. Arrange necessary tests and procedures in accordance with protocol requirements and report results to the investigator. Participate in site visits with the study sponsor to review completeness and accuracy of study documentation. Maintain inventory of all study supplies. Assess potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. Review all eligibility and ineligibility criteria in the patient’s record. Verify information with the physician. Interview patients to obtain information for eligibility assessment, explain the study, and obtain signature for the informed consent form. Conduct a QC check of completed CRFs prior to submission for data entry. Coordinate resolution of all data queries. Complete data entry as warranted. Perform necessary tests as needed and appropriate to level of training such as EKGs, walk tests, etc. Physical Requirements Typical clinical and administrative office setting. Skills & Abilities High degree of organizational talents, data collection, and analysis skills. Meticulous attention to detail. Excellent computer skills including word processing. Ability to prioritize quickly and appropriately. Excellent communication and interpersonal skills. Systematic record‑keeping. Pay Range $44,778.55 - $55,978.47 #J-18808-Ljbffr Tufts Medicine