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Clinical Research Specialist II
2 months ago
GENERAL SUMMARY/ OVERVIEW STATEMENT :
Under the supervision of the Clinical Program Manager within the Division of Transplantation, the Clinical Research Coordinator II plays a pivotal role in the identification, recruitment, and management of study participants, as well as the execution of research protocols. This position involves obtaining informed consent from potential study subjects after they have been thoroughly informed about the study details. Patient management is conducted under the oversight of the Clinical Research Manager and attending physicians. Comprehensive patient data is gathered from various sources, including clinical laboratories, imaging services, and other relevant medical records, and entered into dedicated research databases.
The Coordinator collaborates closely with their supervisor to develop and sustain a database for clinical protocol data, serving as a resource for training other staff members on database utilization. They are responsible for a variety of data management tasks, demonstrating a strong understanding of statistical methodologies, and are tasked with creating visual presentations for manuscripts and oral communications. Additionally, the Coordinator assists in the writing and editing of materials intended for publication.
PRINCIPAL DUTIES AND RESPONSIBILITIES :
The Coordinator manages multiple concurrent clinical research studies (up to 5), with responsibilities that include:
1. Recruitment/Enrollment - Collaborating with Clinical Research RNs and physician investigators, the Coordinator develops and implements strategies for participant recruitment:
Prepares and drafts study consent documents 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 a basic overview of the study and secures informed consent from participants; Organizes and schedules appointments, including the preparation of necessary documentation and data retrieval for participant visits; Accompanies patients to their appointments. Engages with transplant clinical staff to discuss ongoing studies. 2. Regulatory Compliance – Under the guidance of the Principal Investigator and/or Clinical Research Manager, the Coordinator develops and maintains essential protocol documents, IRB amendments, and regulatory submissions. Responsibilities include: Ensuring the accuracy and updating of study forms; Assisting with regulatory submissions, including the preparation and submission of necessary documents to data repositories; Maintaining regulatory documentation for trials within the Division of Transplant; Contributing to protocol recommendations and communicating these with the Clinical Research Manager and RN; Preparing protocols for review by relevant hospital committees; Drafting amendments to protocols based on feedback and submitting for IRB approval; Preparing annual renewals for IRB approval. 3. Data Management - Collects and organizes patient data in compliance with HIPAA regulations: Responsible for data entry related to the study; Utilizes software tools to create graphs and reports; Maintains research data, including patient and study files; Oversees study coding; Assists with formal data audits. 4. General Office & Laboratory Support: Manages bio-sample collection and processing in accordance with study protocols; Ships and stores biological specimens as dictated by study requirements. 5. Undertakes additional administrative and clinical research responsibilities as necessary.SKILLS/ABILITIES/COMPETENCIES REQUIRED :
Exceptional attention to detail, with the ability to work efficiently and accurately with minimal supervision after appropriate training; Proficient in Microsoft Excel, Word, PowerPoint, and data entry skills; Experience with medical record reviews and electronic health records (EPIC) is essential; knowledge of database management is highly preferred; Ability to assess the acceptability of data results; Strong judgment and problem-solving capabilities, with the ability to manage multiple tasks and schedules; 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 dynamic, multidisciplinary team, engaging with diverse individuals at various levels; Flexibility in work hours, with some early morning visits and occasional after-hours responsibilities.EDUCATION:
A Bachelor's degree is required. 1-2 years of experience in research is required.EEO Statement :
Massachusetts General Hospital is an Equal Opportunity Employer.
