Position Description
The department of Orthopedics and Sports Medicine is host to the Clinical Effectiveness Research Center, a collaborative initiative that supports the research efforts of principle investigators, fellows, residents, medical students, and scientists. CERC is comprised of research staff from diverse educational and social backgrounds that assist with the development and execution of a variety of descriptive, observational, and experimental protocols
Clinical Research Manager I Job Summary:

• Manages daily operations of the Clinical Research Studies.
• Develops and oversees the implementation of best practice guidelines for conducting various clinical research protocols.
• Collaborates with Principal Investigators and study stakeholders for management of research studies.
• Manages communication between study staff and internal and external stakeholders.
• Manages and trains the activities of research staff and conducts performance management process.
• Assist in preparing and monitoring clinical laboratory and budgets, maintenance of equipment and ensures compliance with hospital and governmental regulations.

Principal Duties and Responsibilities:

• Leads and manages the work of multiple clinical research projects.
• Serves as Clinical Research Study Trial Manager for one or more large, clinical studies.
• Collaborates and consults with investigators and their staff on the design, development, and conduct of clinical research studies and on clinical research best practices.
• Works with study investigators and statisticians to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
• Collaborates directly with Hospital investigators and CRP scientific staff on developing and writing grants and study protocols.
• Develops curriculum, conducts lectures, and directs courses as part of sponsored educational efforts to train clinical investigators and study staff in clinical research regulations and best practices.
• Leads design and development of data management and data monitoring tools and procedures and supervises data management staff and activities in compliance with GCP and program standards.
• Lead and collaborates with matrix team to design and develop study databases and related products and procedures.
• Manages Staff's Performance Reviews.
• Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures

To qualify, you must have:

• Bachelor's degree and a minimum of 6 years of relevant work experience or Master of Science and 4 years of relevant work experience.
• Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex
• Work requires well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.

Status Full-Time
Standard Hours per Week 40
Job Posting Category Research
Regular, Temporary, Per Diem Regular
Office/Site Location Waltham
Remote Eligibility Part Remote/Hybrid