Brigham and Women's Hospital
Senior Clinical Research Coordinator
Brigham and Women's Hospital, Boston, Massachusetts, us, 02298
Overview
Under the guidance of the Principal Investigator and Senior Project Manager, the Senior Research Clinical Study Coordinator functions independently and proficiently with minimal oversight. They are responsible for the complete coordination of assigned clinical research activities within all phases and complexities of the clinical trial, including investigator-initiated or other high-profile research. Demonstrates competence in clinical research skills, problem solving, priority setting and assists with the management of less experienced staff. Responsibilities
Oversees, prepares, submits and maintains all regulatory submissions (new studies, annual reviews, amendments) in a timely manner. Has a strong understanding of clinical trial endpoints and the ability to sufficiently evaluate and process data. Oversee and/or responsible for the Institutional Review Board (IRB) submissions and other regulatory forms and adhering to the timelines of the study start-up process. Develop informed consent documents, source documents, and other documents as applicable. Responsible for educating new staff and research participants on protocol expectations and proper conduct of clinical trials. Interact with potential study participants and study participants to implement protocol with fidelity. Provide participant education, procedural instruction, and follow-up. Serve as a liaison between study participant and research team. Responsible for collecting data and maintaining participant information database for study. May be required to input data, do minimum analysis and run various reports. Support the safety of clinical research participants. Understand and proficiently communicate all components of research documents, such as protocol, informed consent, investigator brochure and research instructions. Responsible for mailing various study information or packets to study participants. Answer any phone calls and inquiries regarding study protocol. Refer participants to principal investigator or co-investigators as clinically indicated. Responsible for training and orienting all new staff. Interact with study monitors, scheduling monitoring visits as indicated, and providing timely responses to study queries. Maintain study inventory and order study supplies when necessary. Ensures the appropriate delegation of study related tasks (i.e.: Delegation of Authority) on all protocols. Communicate with participant's clinical care providers as needed and document research visits within electronic health record system, in compliance with institutional policies. Contribute to research team environment, serving as back-up coordinator to support other studies in department, cross-training/peer-mentoring other team members, and contributing to research meetings. All other duties, as assigned. Education
Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred Can this role accept experience in lieu of a degree? Yes Experience
Related post-bachelor's degree research experience 3-5 years required Knowledge, Skills and Abilities
Ability to work more independently and as a team member. High degree of computer literacy and analytical skills. Ability to identify both technical and non-technical problems and develop solutions. Ability to interpret acceptability of data results. Highly proficient data management skills and working knowledge of data management systems. Able to display initiative to introduce innovations to research study. Excellent time management, organizational, interpersonal, written, and verbal communication skills. Physical Requirements
Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Equal Opportunity
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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Under the guidance of the Principal Investigator and Senior Project Manager, the Senior Research Clinical Study Coordinator functions independently and proficiently with minimal oversight. They are responsible for the complete coordination of assigned clinical research activities within all phases and complexities of the clinical trial, including investigator-initiated or other high-profile research. Demonstrates competence in clinical research skills, problem solving, priority setting and assists with the management of less experienced staff. Responsibilities
Oversees, prepares, submits and maintains all regulatory submissions (new studies, annual reviews, amendments) in a timely manner. Has a strong understanding of clinical trial endpoints and the ability to sufficiently evaluate and process data. Oversee and/or responsible for the Institutional Review Board (IRB) submissions and other regulatory forms and adhering to the timelines of the study start-up process. Develop informed consent documents, source documents, and other documents as applicable. Responsible for educating new staff and research participants on protocol expectations and proper conduct of clinical trials. Interact with potential study participants and study participants to implement protocol with fidelity. Provide participant education, procedural instruction, and follow-up. Serve as a liaison between study participant and research team. Responsible for collecting data and maintaining participant information database for study. May be required to input data, do minimum analysis and run various reports. Support the safety of clinical research participants. Understand and proficiently communicate all components of research documents, such as protocol, informed consent, investigator brochure and research instructions. Responsible for mailing various study information or packets to study participants. Answer any phone calls and inquiries regarding study protocol. Refer participants to principal investigator or co-investigators as clinically indicated. Responsible for training and orienting all new staff. Interact with study monitors, scheduling monitoring visits as indicated, and providing timely responses to study queries. Maintain study inventory and order study supplies when necessary. Ensures the appropriate delegation of study related tasks (i.e.: Delegation of Authority) on all protocols. Communicate with participant's clinical care providers as needed and document research visits within electronic health record system, in compliance with institutional policies. Contribute to research team environment, serving as back-up coordinator to support other studies in department, cross-training/peer-mentoring other team members, and contributing to research meetings. All other duties, as assigned. Education
Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred Can this role accept experience in lieu of a degree? Yes Experience
Related post-bachelor's degree research experience 3-5 years required Knowledge, Skills and Abilities
Ability to work more independently and as a team member. High degree of computer literacy and analytical skills. Ability to identify both technical and non-technical problems and develop solutions. Ability to interpret acceptability of data results. Highly proficient data management skills and working knowledge of data management systems. Able to display initiative to introduce innovations to research study. Excellent time management, organizational, interpersonal, written, and verbal communication skills. Physical Requirements
Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Equal Opportunity
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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