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Clinical Research Specialist II
2 months ago
GENERAL SUMMARY/ OVERVIEW STATEMENT :
Under the guidance of the Clinical Program Manager for the Division of Transplantation, the Clinical Research Coordinator II plays a vital role in the identification, recruitment, and management of study participants while ensuring the smooth execution of research protocols. The Coordinator is responsible for obtaining informed consent from participants once they have been adequately informed about the study's objectives and procedures. Patient oversight is conducted under the supervision of the Clinical Research Manager and associated physicians. Data collection from various sources, including clinical labs and patient records, is essential for maintaining accurate research databases.
Collaborates closely with supervisors to establish and uphold a comprehensive database of clinical protocol information. The Coordinator serves as a resource for educating staff on database management. Engages in a variety of data management tasks, demonstrating a solid understanding of statistical principles; responsible for creating visual aids for manuscripts and presentations. Works with supervisors to draft and refine materials intended for publication.
PRINCIPAL DUTIES AND RESPONSIBILITIES :
Manages multiple concurrent clinical research projects (up to 5), with key responsibilities including:
1. Recruitment/Enrollment - In collaboration with Clinical Research RNs and physician investigators, formulates and executes strategies for participant recruitment:
Prepares study consent documentation for review by the Principal Investigator and Institutional Review Board; Conducts interviews and screens potential study participants; Acts as a resource for patients and their families regarding the study; Confirms participant eligibility based on inclusion/exclusion criteria; Provides an overview of the study and secures informed consent from participants; Organizes and manages paperwork for participant visits; Accompanies patients to their appointments. Engages with transplant clinical staff to discuss ongoing studies. 2. Regulatory Compliance – Under the direction of the Principal Investigator and/or Clinical Research Manager, develops and maintains protocol-specific documentation, including IRB amendments and regulatory submissions. Responsibilities include: Ensuring the accuracy and updates of study forms; Assisting with regulatory submissions, including the preparation of documents for data repositories; Maintaining regulatory documentation for trials; Contributing to protocol recommendations and communicating these with the Clinical Research Manager; Preparing protocols for review by necessary hospital committees; Drafting amendments to protocols based on feedback and submitting for IRB approval; Preparing annual renewal submissions for IRB approval. 3. Data Management - Collects and organizes patient data from medical records and other sources, adhering to HIPAA regulations: Enters study data into databases; Utilizes software to generate reports and visual representations; Maintains research data and participant files; Manages study codes; Assists with formal data audits. 4. General Office & Laboratory Support: Oversees the collection and processing of biological samples in accordance with study protocols; Manages the shipping and storage of specimens as required. 5. Takes on additional administrative and clinical research responsibilities as necessary.SKILLS/ABILITIES/COMPETENCIES REQUIRED :
Exceptional attention to detail and the ability to work efficiently with minimal supervision after receiving appropriate training; High proficiency in Microsoft Excel, Word, PowerPoint, and data entry skills; Experience with medical record reviews and electronic health records is essential; knowledge of database management is highly preferred; Ability to interpret data results effectively; Strong judgment and problem-solving capabilities, with the ability to manage multiple tasks and schedules; Demonstrates professionalism, compassion, and respect for the rights and needs of study participants; Excellent verbal and written communication skills in English; Ability to work independently and collaboratively within a multidisciplinary team, engaging with diverse individuals at various levels; Flexibility in work hours, with some visits scheduled early in the morning and potential for occasional work outside standard hours. QualificationsEDUCATION:
Bachelor's degree is required. 1-2 years of experience in research-related roles is required.EEO Statement :
Massachusetts General Hospital is an Equal Opportunity Employer.
