Clinical Research Coordinator II, Ophthalmology

BMC Software • Boston, MA

1d • Onsite

About The Position

At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our patients and our commitment to ensure everyone who comes through our doors has a positive experience. You’ll find a supportive work environment at BMC, with rich opportunities throughout your career for training, development, and growth and where you’ll have the tools you need to take charge of your own practice environment. POSITION SUMMARY: Under the supervision of the Lead CRC, Senior Research Manager and Principal Investigator for assigned research studies, the Clinical Research Coordinator (CRC) II will perform research activities using approved techniques. The CRC procures, processes and ships research specimens and conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases, enters data into sponsor-specific electronic data capture forms, performs administrative tasks, assists in grant preparation, and participates with the research team in preparation of data and other reports. Will also assist with audits and quality improvement projects.

Requirements

• Baccalaureate Degree Required
• Excellent English communication skills (oral and written).
• Cultural sensitivity and comfort with a wide range of social, racial, and ethnic populations.
• Must be able to maintain strict confidentiality of all personal/health-sensitive information.

Nice To Haves

• Master’s Degree preferred
• 2-5 years experience
• Prefer candidates with ophthalmology technician background
• Bilingual or multi-lingual skills (beyond that of English) appropriate to the patient population served is a plus.
• Training in biostatistics and experience with statistical software programs preferred.

Responsibilities

• Study Coordination: Ensuring smooth and efficient running of clinical trials, includes coordinating with the PI, research team, and clinic staff for completing research visits seamlessly.
• Maintaining study timelines, binders, and supplies, Ensuring adherence to protocols, good clinical practices (GCP) guidelines, and regulatory requirements.
• Conducting and/or assisting in study specific tasks such as patient work-up (vision testing, refraction), ocular imaging, and Biospecimen collection.
• Perform various ophthalmology tests on research participants. Tests may include: Visual Acuity Testing, Visual Field Testing, Refraction, Ocular Imaging as per research protocol such as Fundus Photography, Optical Coherence Tomography (OCT), etc.
• Participant Management Recruiting and screening potential participants, ensuring they meet study eligibility criteria.
• Obtaining informed consent from participants, explaining the study’s purpose, risks, and any potential benefits.
• Monitoring participant safety and well-being, reporting any adverse events to the PI and sponsor in consultation with the research manager.
• Data Management Collecting, documenting, and managing study data accurately and efficiently as per approved methods.
• Being familiar and facile with data management software such as Microsoft excel and RedCap Review data for quality and completeness based on established queries.
• Ensuring data integrity and compliance with data management procedures.
• Preparing data for analysis and reporting.
• Regulatory Compliance and Documentation: Write up regulatory applications and submissions prior to initiating the research studies.
• Liaisons with Institutional Review Board (IRB) to facilitate approval of projects, ongoing documentation, and reporting.
• Maintaining accurate and up-to-date study documentation, including regulatory binders and source documents.
• Ensuring compliance with institutional review board (IRB) requirements and ethical guidelines.
• Preparing and submitting necessary documentation to the PI, IRB, and sponsor.
• Communication and Collaboration: Serving as a liaison between the research team, participants, and clinic staff for efficient communication.
• Providing training to research and clinical staff on study protocol and facilitate study certification tasks.
• Other responsibilities include but not limited to: Assists with new grant proposal development, and preparation of research reports and presentations.
• Perform administrative duties associated with the study’s Data Monitoring and Safety Board, tracking and reporting adverse events and collecting data specified by the DMSB.
• Participates in staff meetings/initiatives including appropriate quality improvement and education activities, or if unable to attend non-mandatory activities, accepts responsibility to review meeting minutes and becomes knowledgeable of issues discussed.
• Conforms to hospital standards of performance and conduct, including those pertaining to patient rights, so that the best possible customer service and patient care may be provided.
• Utilizes hospital's behavioral standards as the basis for decision making and to facilitate the hospital’s goals and mission.
• Follows established hospital infection control and safety procedures.
• Assist with additional protocols and training as they arise.

Benefits

• Competitive pay
• Tuition reimbursement and tuition remission programs
• Highly subsidized medical, dental, and vision insurance options
• Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
• Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level