Clinical Research Specialist II

1 week ago

Boston, Massachusetts, United States Massachusetts General Hospital Full time

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 effective execution of research protocols. This position involves obtaining informed consent from potential study subjects after they have been thoroughly educated about the research initiative. Patient management is conducted under the supervision of the Clinical Research Manager and attending physicians. Data collection is performed from various sources, including clinical laboratory results, imaging studies, and other relevant patient documentation, which is then entered into research databases.

The Coordinator collaborates with their supervisor to develop and sustain a comprehensive database of clinical protocol information. They serve as a resource for training other staff members on database usage. This role encompasses a variety of moderate to complex data management tasks, demonstrating a solid understanding of statistical principles and their application; the Coordinator is also responsible for creating visual aids for publications and presentations. They work alongside their supervisor in drafting and refining materials intended for publication.

PRINCIPAL DUTIES AND RESPONSIBILITIES :

The Coordinator is responsible for managing multiple concurrent clinical research studies (up to 5), with key responsibilities including:

1. Recruitment/Enrollment - Collaborating with Clinical Research RNs and physician investigators in the Division of Transplantation to devise and implement effective recruitment strategies:

Drafting and preparing study consent documents for Principal Investigator and Institutional Review Board review; Conducting interviews and screenings of potential study participants; Acting as a resource for patients and their families regarding the study; Verifying inclusion/exclusion criteria for study subjects; Providing a basic overview of the study and securing informed consent from participants; Organizing and coordinating paperwork and data retrieval for participant visits; Accompanying patients to their appointments. Engaging with transplant clinical staff to discuss ongoing studies. 2. Regulatory Compliance – Under the oversight of the Principal Investigator and/or Clinical Research Manager, the Coordinator develops and maintains protocol-specific documentation, IRB amendments, and regulatory submissions. Responsibilities include: Ensuring the accuracy and timely updates of study forms; Assisting with regulatory submissions, including the preparation and submission of documents to data repositories; Maintaining regulatory binders for clinical trials; Contributing to protocol recommendations and communicating these with the Clinical Research Manager and RN; Preparing protocols for review by necessary hospital subcommittees; Drafting amendments to protocols based on feedback and submitting for IRB approval; Preparing annual renewals for IRB approval. 3. Data Management - Collecting and organizing patient data from medical records and healthcare providers while adhering to HIPAA regulations: Entering study data into databases; Utilizing software to generate reports and graphical representations; Maintaining research data, patient files, and study documentation; Managing study codes; Assisting with formal data audits. 4. General Office & Laboratory Support: Overseeing the collection and processing of biological samples in accordance with study protocols; Managing the shipping and storage of specimens as required by the research protocol. 5. Undertaking additional administrative and clinical research responsibilities as needed.

SKILLS/ABILITIES/COMPETENCIES REQUIRED :

Exceptional attention to detail and the ability to work independently and efficiently following 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 skills, with the capacity to manage multiple tasks and schedules; Professionalism, compassion, and respect for the rights and needs of study participants; Excellent oral and written communication skills in English; Ability to work both independently and collaboratively within a multidisciplinary team, engaging with diverse individuals at various levels; Flexibility in work hours, as some visits may occur early in the morning or outside of standard business hours.

EDUCATION:

A 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.

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