Clinical Research Coordinator

3 weeks ago

Boston, United States Massachusetts General Hospital Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Massachusetts General Hospital Stroke and Neurocritical Care Research Center is one of the largest and most prolific stroke research centers in the country employing a diverse team of clinical researchers managing novel clinical trials in stroke and vascular diseases. The Center's staffing structure and project portfolio support professional growth of clinical research staff at all levels as well as successful facilitation of highly complex interventional trials and large-scale genetic, longitudinal and observational studies.

The Clinical Research Coordinator will work with a dynamic team of investigators, coordinators and fellows to coordinate multiple inpatient and outpatient neurologic studies involving patients from diverse clinical settings, including, but not limited to, the emergency department, neurosurgery, neurointensive care unit, and ambulatory stroke clinics. They will be responsible for the day-to-day coordination of assigned longitudinal, observational and/or interventional clinical research studies including patient-facing recruitment/enrollment activities and facilitation of study-specific administrative and regulatory activities.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Specific Responsibilities include but are not limited to:

* Assists with screening, informed consent, and enrollment of patients
* Administers standardized testing tools to subjects
* Coordinates and/or performs study procedures including interviews, vital signs, blood draws and sample processing
* Conducts subject interviews and assessments of subjects' well-being and cognitive function, both in-person and by telephone, and maintains the data
* Completes and maintains study screening logs, IRB documentation, regulatory files, source documentation, and case report forms
* Collects and enters data as specified by protocols
* Meets regularly with study PIs to review subject and study data and assists with the monitoring for and reporting of adverse events and protocol deviations
* Assists with writing and altering protocols, informed consents and other study documents.
* Works with Program Manager and PI to prepare study reports and assists with drafting grant applications
* Searches medical literature and retrieves journal articles and other references
* Acts as a study resource for patients, families and staff
* Schedules and performs study follow-up visits including neuropsychological testing batteries, MRIs/PET imaging, blood draws and sample processing
* Maintains inventory, stocks and orders supplies. Calibrates or updates study equipment
* Actively participates in meetings and teleconferences with other research colleagues by organizing and presenting study screening and enrollment results, sharing best practices, and troubleshooting challenges
* Takes call one weekend per month and 5 weeknights per month to help cover off hour study enrollments and procedures
* Collects and prepares data for monitoring, audits, and analysis by following Quality Assurance and Quality Control procedures, and participates in data monitoring/ audits
* Assists with other research-related administrative tasks as needed

Candidates with 1-2 years of clinical research experience may be considered for a Clinical Research Coordinator II (CRC II) position. The CRC II performs the duties of the CRC I (above) and may also:

* Drafts and submits applications to the IRB, including initial submissions, amendments, and continuing reviews
* Creates standard operating procedures to standardize trial activities at the site
* Creates and executes project-specific and/or general training sessions for new and/or junior staff
* Develops and implements recruitment strategies

SKILLS & COMPETENCIES REQUIRED:

The Clinical Research Coordinator position is ideal for someone interested in pursuing graduate studies or a career in the fields of medicine, neuroscience or clinical research. It involves extensive patient interaction as a member of a clinical research team.

* The successful candidate will be highly motivated, eager to interact with patients with neurologic illness and their families in a variety of fast-paced hospital settings (ED, ICU, and clinics), and curious about diseases of the brain.
* Ability to take call approximately one weekend and 5 weeknights a month is required.
* A high level of maturity is essential, as the coordinator is given access to personal and confidential medical information.
* Strong organizational and interpersonal skills, attention to detail, and the ability to prioritize multiple tasks are essential.
* Must demonstrate analytical skills, ability to resolve technical problems, ability to interpret acceptability of data results and have a working knowledge of data management programs.

Candidates for Clinical Research Coordinator II should also possess:

* Ability to work independently and as a team player
* Analytical skills and ability to resolve technical and/or operational problems
* Ability to interpret acceptability of data results
* Leadership skills and comfort mentoring, training or supervising the work of new or more junior clinical research personnel
* Understanding of industry standards including Good Clinical Practice principles, IRB reporting requirements and expectations and best practices for conducting clinical research in humans.

Minimum Technical Standards:

Comfort with computers, specifically the Windows operating system, is essential. Proficiency in Microsoft Word, Outlook, Powerpoint, Access and Excel, as well as the ability to learn how to use new software is also important. Staff member will be trained in clinical skills as warranted by project-specific requirements (these may include phlebotomy, facilitation of EKGs, collection of vital signs or other clinical measures).

EDUCATION:

* Bachelor's degree required.

EXPERIENCE:

* New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
* Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position. For these candidates, experience with facilitation of clinical skills (phlebotomy, EKGs, vital signs) and experience with research IRB submission processes preferred.

SUPERVISORY RESPONSIBILITY (if applicable):

* A Clinical Research Coordinator I does not have any supervisory responsibility.
* A Clinical Research Coordinator II may assist with the training and orientation of new staff members.

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