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Clinical Research Coordinator II - Autism and Developmental Disorders Research Program

Company: Maine Medical Center
Location: Portland
Posted on: November 20, 2022

Job Description:

Summary Position Summary Make a difference by working in clinical research studies of children with autism and other developmental disabilities.This position will coordinate the activities of enrollment and data collection for a range of protocol designs to ensure participant safety and protocol compliance in accordance with the code of federal regulations and good clinical practice Essential Functions Study Coordination Identify, screen and interview potential study subjects and their families. Conduct the informed consent process with potential participants and their families.This includes explaining the project and all associated benefits/risks, answering any questions, obtaining signatures on legal documents and providing continual informed consent throughout protocol participation. Ensure the safety and protection of subjects enrolled in a research study. Schedule subject assessments/visits as necessary. Assure all study tests, visits, and assessments are done at appropriate time intervals. Biospecimen sample collection and processing (such as blood, saliva, etc.) Observe participants and review medical records to record required protocol data and document protocol adherence Assess subjects for signs of potential adverse events. Report all suspected adverse events to the appropriate personnel/regulatory agencies. Complete case report forms by obtaining, compiling, and maintaining necessary documentation. Facilitate studies by coordinating study related activities with other departments and staff. Compliance and Audit Coordination Comply with FDA regulations and International Conference on Harmonization(ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials. Coordinate and maintain regulatory documents, including the Institutional Review Board (IRB) application, research plan and writing the informed consent. Facilitate inspections and audits from industry personnel and regulatory agencies including internal reviews. Demonstrates competency in informed consent. Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates expected within two years of hire. Collaboration Provide day to day support to Clinical Research Coordinator I roles on the Autism and Developmental Disorders research team Develop collaborative relationships with Spring Harbor Hospital personnel and other external organizations in the support of conducting active research protocols Be a primary resource to Clinical Research Coordinators from outside institutions that are part of the Autism and Developmental Disorders Inpatient Research Collaborative (ADDIRC) Collaborate on the design of departmental research projects. Collaborate in the development of research related data collection methods.This includes designing case report forms, and associated databases. Communication Interact with industry and community personnel involved with potential and ongoing scientific research. Coordinates activities of the Autism and Developmental Disorders Inpatient Research Collaborative (ADDIRC). This includes orienting new research coordinator members, scheduling meetings, setting agendas, facilitating network CRC meetings and keeping minutes. Required Minimum Knowledge, Skills, and Abilities (KSAs)Education: Bachelor's degree in a health science or related field required. License/Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred. Experience: 2 years of clinical experience in a healthcare setting required. Knowledge of basic statistical principles and methods. Ability to function independently and as part of a team. Excellent communication skills, verbal and written. Demonstrable computer competency in Microsoft Word and Excel. Additional Information MaineHealth was ranked one of America's Best Large Employers in 2022 by Forbes! MaineHealth is a not-for-profit integrated health system whose vision is, "Working together so our communities are the healthiest in America."MaineHealth consists of nine local health systems, a comprehensive behavioral health care network, diagnostic services, home health agencies, and 1,700 employed clinicians working together through the MaineHealth Medical Group. With approximately 22,000 care team members, MaineHealth provides preventive care, diagnosis and treatment to 1.1 million residents in Maine and New Hampshire. Learn more about our system at mainehealth.org At MaineHealth, we offer benefits that support an individual's needs for today and flexibility to plan for tomorrow. Our packages include health and dental insurances, paid parental leave, retirement program, generous paid time off, and much more! Our comprehensive array of benefits are competitive, affordable, and include choices that meet specific, but ever changing, needs. With a career at any of the MaineHealth locations, you'll be working with health care professionals that truly value the people around them - both within the walls of the organization and the neighborhoods that surround it. We are deeply invested in the well-being of our communities and care team members. We believe in fostering a work environment of strong commitment, compassionate caring and continuous improvement. Join us, and your abilities will be challenged and enhanced as you take your career to a new level.Additional Information Maine Medical Center is a Magnet designated 700-bed tertiary care and teaching institution. MMC is Maine's largest hospital and a state-wide health care resource. MMC offers outstanding career opportunities and quality of life in Portland.

Keywords: Maine Medical Center, Portland , Clinical Research Coordinator II - Autism and Developmental Disorders Research Program, Other , Portland, Maine

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