Clinical documentation specialist [h1.location_city]

Job Summary

The Clinical Research Specialist (CRS) is responsible for supporting and / or conducting clinical study activities and basic data collection at clinical sites, as well as managing assigned clinical projects & operations, including pre-monitoring activities, data entry, inventory management, device procurement, shipping, and financial management. Supports CRAs with IRB submissions, site training, tracking study progress and performance, and generating reports which includes interacting and communicating with site staff and key study personnel. Ensures all activities are conducted in accordance with regulations (FDA, EU MDR, and other international regulations), Good Clinical Practices (GCP), department standard operating procedures, and Masimo’s guiding principles including Masimo’s code of conduct and highest ethics.

Duties & Responsibilities

• Plan, implement and conclude clinical studies in support of project timelines / market release goals.
• Prepare and document study plans, contracts, budgets, informed consents, support IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage, and accuracy across all assigned projects.
• Contribute to clinical study design, proposals, protocols, etc., understanding basic scientific content, experimental design, and analytical approaches used.
• Effectively work and communicate with investigator, staff, and patients in professional, sensitive, and mature manner.
• Conduct or assist with site monitoring under direct supervision of Manager or Senior CRAs (qualification, initiation, monitoring and close out visits) to ensure and document site is trained to follow study procedures per protocol.
• Attend meetings and recap discussions for internal and external distributions.
• Support TMF maintenance including Site and Sponsor communications along with all study related documentation.
• Order equipment for Masimo studies, managing inventory and shipments to study sites; follow SOP to ensure device accountability and proper labeling.
• Track spending for reporting and accruals.
• Perform data entry, verification, and organization of data files.
• Support the department with conduct of Sponsored and Investigator Initiated Studies; work with Clinical Research Associates and Managers to support them on projects and tasks.
• Support data collection duties, including equipment setup and operations, execution of study per procedures and data collection.
• Support / conduct moderate data analysis using spreadsheet and statistical programs, and organize reports of data in simple clear fashion with appropriate tables, charts, and graphs.
• Pack, ship, move, unpack, set up and executive equipment for study at clinical site, repacking, and shipping back to Masimo.
• Perform other duties and projects as assigned.

Minimum Qualifications :

Preferred Qualifications :

Education

Bachelor’s degree preferred.

Compensation

Physical requirements / Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Must be able to lift and carry up to 20 pounds. Some local travel and domestic / international travel up to 25-50%, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

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