Clinical Research Coordinator II NEUROLOGY HL
Brigham and Women's Hospital, Boston, MA, United States
Overview
Working under the supervision of the Administrative Director of the CNCT and the Principal Investigator and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; maintaining and updating data generated by the study, all IRB submissions such as applications, amendments, annual reviews and adverse events, and communicating with national and international research collaborators.
Responsibilities
Assist with clinical research studies as per study guidelines and protocols.
Screen for eligibility, recruit and evaluate potential study patients. Per protocol instruction, conduct telephone interviews or schedule patients for in-person study visits and screening.
Perform clinical tests such as questionnaires or cognitive assessments if certified and as needed. Work with colleagues in research labs to set up lab testing, shipping, etc.
Collect data and maintain the patient information database for several studies. Input data as required. Maintain study subject records as part of the record-keeping function. Prepare data for analysis and data entry.
Interact with patients/subjects regarding the studies, including patient education, procedural instruction, and follow-up. Prepare materials to advertise studies. Answer phone calls and inquiries regarding study protocol. Refer participants when appropriate to supervisor or clinical staff.
Serve as a liaison between patient and physician. Be the first point of contact for study communications. Advocate for patients to ensure a good experience while in the trial and assure compliance.
Communicate with sponsor companies, CRAs, central labs, and testing facilities, both external and internal.
Schedule all research meetings with monitors or sponsors.
Create, distribute, and file all study documents per protocol and update them as needed.
Manage study information or packets, such as schedules, directions, and reimbursements to study participants.
Oversee staff study training.
Prepare and submit all IRB documents: applications, amendments, annual reviews, and serious adverse events.
Oversee study budgets and patient reimbursements.
Monitor and set up any needed equipment; maintain inventory and order supplies as necessary.
Maintain all study regulatory documents and perform other research administrative tasks as assigned.
Comply with all policies and standards.
Education
Bachelor's Degree Science required
Can this role accept experience in lieu of a degree?
No
Experience
Related post-bachelor's degree research experience 1-2 years required
Knowledge, Skills and Abilities
Excellent interpersonal skills are required to work with the study participants, PIs, research collaborators, colleagues and supervisors.
Good oral and written communication skills.
Knowledge of clinical research protocols.
Knowledge of GCP and ICH guidelines.
Knowledge of computer programs, databases, etc.
Able to work independently.
Able to multi-task on several projects simultaneously and shift focus multiple times per day.
Able to work under deadline pressure.
Ability to problem solve quickly and accurately.
Excellent organizational skills and ability to prioritize and delegate a variety of tasks.
Careful attention to detail.
Ability to demonstrate professionalism and respect for subjects' rights and individual needs.
Ability to work with vulnerable subjects (pregnant women with neurologic illness).
Basic knowledge of human anatomy, physiology, pharmacology.
Equal Opportunity Employer
The Brigham and Women’s Hospital, Inc. is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
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Working under the supervision of the Administrative Director of the CNCT and the Principal Investigator and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; maintaining and updating data generated by the study, all IRB submissions such as applications, amendments, annual reviews and adverse events, and communicating with national and international research collaborators.
Responsibilities
Assist with clinical research studies as per study guidelines and protocols.
Screen for eligibility, recruit and evaluate potential study patients. Per protocol instruction, conduct telephone interviews or schedule patients for in-person study visits and screening.
Perform clinical tests such as questionnaires or cognitive assessments if certified and as needed. Work with colleagues in research labs to set up lab testing, shipping, etc.
Collect data and maintain the patient information database for several studies. Input data as required. Maintain study subject records as part of the record-keeping function. Prepare data for analysis and data entry.
Interact with patients/subjects regarding the studies, including patient education, procedural instruction, and follow-up. Prepare materials to advertise studies. Answer phone calls and inquiries regarding study protocol. Refer participants when appropriate to supervisor or clinical staff.
Serve as a liaison between patient and physician. Be the first point of contact for study communications. Advocate for patients to ensure a good experience while in the trial and assure compliance.
Communicate with sponsor companies, CRAs, central labs, and testing facilities, both external and internal.
Schedule all research meetings with monitors or sponsors.
Create, distribute, and file all study documents per protocol and update them as needed.
Manage study information or packets, such as schedules, directions, and reimbursements to study participants.
Oversee staff study training.
Prepare and submit all IRB documents: applications, amendments, annual reviews, and serious adverse events.
Oversee study budgets and patient reimbursements.
Monitor and set up any needed equipment; maintain inventory and order supplies as necessary.
Maintain all study regulatory documents and perform other research administrative tasks as assigned.
Comply with all policies and standards.
Education
Bachelor's Degree Science required
Can this role accept experience in lieu of a degree?
No
Experience
Related post-bachelor's degree research experience 1-2 years required
Knowledge, Skills and Abilities
Excellent interpersonal skills are required to work with the study participants, PIs, research collaborators, colleagues and supervisors.
Good oral and written communication skills.
Knowledge of clinical research protocols.
Knowledge of GCP and ICH guidelines.
Knowledge of computer programs, databases, etc.
Able to work independently.
Able to multi-task on several projects simultaneously and shift focus multiple times per day.
Able to work under deadline pressure.
Ability to problem solve quickly and accurately.
Excellent organizational skills and ability to prioritize and delegate a variety of tasks.
Careful attention to detail.
Ability to demonstrate professionalism and respect for subjects' rights and individual needs.
Ability to work with vulnerable subjects (pregnant women with neurologic illness).
Basic knowledge of human anatomy, physiology, pharmacology.
Equal Opportunity Employer
The Brigham and Women’s Hospital, Inc. is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
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