Posted in General Business 30+ days ago.
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Location: Boston, Massachusetts
The Research Nurse Coordinator assists principal investigators and research teams in the development and implementation of clinical research in the Dept. of Psychiatry, which primarily includes clinical research with individuals with substance use disorders but may also include other areas of clinical research within psychiatry. Duties may vary by based on each research study, but typically include: conducting informed consent, assessing patients' condition, readiness and eligibility for study enrollment as a research subject, conducting/rating clinical assessments for research, dispensing or administering study medication, completing case report forms, data quality assurance (QA), biospecimen preparation, and preparation of research reports and statistical interpretation. Duties also include study subject recruitment, assigning tasks and projects, collection of data and analysis and performing other related duties. Personnel management responsibilities include facilitating on-boarding of new personnel (e.g., training staff in vital signs and ECG). Ensures that all projects are in compliance with all public health, state and federal agencies policies and procedures.
ESSENTIAL RESPONSIBILITIES / DUTIES:
Responsible for a variety of specialized clinical research activities. Ensures that established protocols are implemented, maintains protocol integrity, monitors participant’s status assuring safety, and plays a significant role in the education of clinical staff and clinical trial participants. Working with the PIs, determines whether patients meet protocol inclusion criteria and assists with research subjects recruitment. Drafts study subject consent forms, data collection forms, and IRB applications as needed. Conducts informed consent. Performs initial assessment and intake obtaining social, medical, mental health, substance abuse and medication history. Reviews intake assessment with clinical team to review patients' condition, readiness, eligibility for study enrollment as a research subject and to establish appropriate plan of care for patient. Orders, interprets, and evaluates appropriate lab and diagnostic tests tin order to develop individualized treatment and follow-up plan for each study subject. Provides patient education regarding protocol participation and provides additional information to participants to ensure their understanding and adherence to the program. Acts as a liaison between primary care and specialty physicians, inpatient/outpatient nurses, and other clinical providers to refer patients for additional care outside of the research spectrum. Completes case report forms for assigned patients. Evaluates case report forms for accuracy and compliance to protocol. Submits completed case report forms to protocol sponsor within the required timeline. Performs consistency checks, error edits, and monitors timeliness of data submission to sponsors. Performs all aspects of the clinical data collection, research progress, adverse events, informed consent, and the medical care and response to the study treatment. Responsible for collection and entry of clinical research data, and responds in a timely manner to all authorized queries related to the clinical research data. Serves as a liaison and reference to physicians, investigators and other staff members with questions regarding data collection and protocol, procedures and requirements. Adheres to all applicable federal code (e.g. 45CFR46), institutional policies, State and federal law, and guidance for conducting clinical research (e.g. Good Clinical Practice) and Standard Operating Procedures (SOPs). Adheres to protocol requirements to ensure validity of clinical research patient data. Consistently uses clear concise and effective communication written/oral and comply with departmental policies when sharing/documenting relevant patient care data. Participates in conferences related to the clinical research projects. 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. Assist in phone triage, follow up of test results, critical values and medical issues.
Reviews staff’s work and ensures that work is completed properly; determines employee proficiencies and training opportunities Facilitates hiring/on-boarding of new research staff Contributes to the design and implementation of trainings for new research staff hires Provides supervision, clinical assignments, and day to day operations of assigned staff
Provides education to department staff with focus on research (clinical trial) treatment, medical complications related to disease and treatment of these diseases and complications Perform orientation groups for new patients to the clinic, including identifying symptoms, side-effects, treatment, wellness, co-morbidities and self-help measures.
Performs other duties as assigned or as necessary.
Must adhere to all of BMC’s RESPECT behavioral standards.
(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).
JOB DESCRIPTION CHARACTERISTICS
Graduate from an accredited nursing program, associate's, or bachelor's of science degree program; BSN preferred.
CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:
Licensed to practice professional nursing as a registered nurse (RN) in the Commonwealth of Massachusetts. Current basic cardiac life support certification.
Five or more years of nursing experience is highly preferred.
Two years of experience with clinical research required; clinical trials research experience preferred.
Experience working with patients with substance use disorders preferred.
KNOWLEDGE AND SKILLS: