Clinical Research Coordinator II

Working under general supervision from the Principal Investigator, Senior Project Manager, and following established policies and procedures, the CRC II will provide direct assistance on clinical research study start-up, study implementation as well as coordinate all clinical research and administrative procedures per the study protocol for the successful management of clinical trials. PRINCIPAL DUTIES AND RESPONSIBILITIES: Provide assistance on clinical research studies as per studies guidelines and protocols. 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. Recruit and evaluate potential study participants. Adhere to protocol requirements for all study conduct. May be required to perform clinical tests such as phlebotomy, EKG's, vital signs, coordinate visits and specimen collection. 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 using all types of communication methods for various studies 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 new staff. May serve as a team leader or in a supervisory capacity in a smaller area. 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 Science required

Can this role accept experience in lieu of a degree? Yes

Licenses and Credentials

Experience Related post-bachelor's degree research experience 1-2 years required

Knowledge, Skills and Abilities - Ability to work more independently and as a team member. - Computer literacy, analytical skills, and ability to resolve technical problems. - Ability to interpret the acceptability of data results. - Working knowledge of data management programs. 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%)

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.