Job Description

WHO WE WANT:

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 

Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

As the Clinical Study Associate (CSA) you will assist the Clinical Study Manager (CSM) with administrative aspects of clinical studies including Investigational Device Exemption (IDE), post-approval, post-market surveillance, feasibility and/or marketing studies. This role will be focused on global market access, market adoption and EUMDR for Stryker Joint Replacement products.

The Clinical Study Associate is responsible for ensuring operational aspects of the studies such as documentation, payments and other systems are being conducted in accordance with GCPs, Food and Drug Administration regulations and department Standard Operational Procedures.

Support Clinical Study Manager in development and maintenance of study records

Perform center activation tracking ensuring receipt of proper study documentation

Support Clinical Study Manager in preparation and maintenance of patient recruitment and retention strategies

Actively participate in the design, development, and testing of the Case Report Forms (CRFs) and database.  Work with programmer analyst to set up error checking report and other study reports

Support Clinical Study Manager on data management functions including SAS reports, review of program specifications, User Acceptance Test and edit checks approval

Prepare monitoring visit materials

Prepare training materials for clinical studies

Assist the Clinical Study Manager with site visits and training of site personnel

Perform investigational device tracking process

Coordinate pre and post-monitoring activities for monitors

Review monitoring visit reports and follow up on observations

Perform monitoring and co-monitoring as required

Review completed CRFs for consistency and produce queries to site for corrections

Review adverse events forms and report observations to Clinical Study Manager

Assist Clinical Study Manager with periodic mailings to sites for data issues and study communication

Assist Clinical Study Manager on study development and management activities for assigned studies and/or develop and manage assigned studies

Assist Clinical Study Manager with and/or manage facilitation of publishing study results in peer reviewed journals

May identify and support research sites within the region

Serve as liaison between clinical personnel, site personnel, and Stryker field personnel

Process and track Investigator payments and patient reimbursements

Set up filing, documentation management and tracking systems

Assists Clinical Study Manager with study closure activities

WHAT YOU NEED:

Bachelor’s degree required. (Bachelor’s degree in science, business, or health-related field preferred)

0+ years related work experience required

1+ years related clinical trial associate, clinical study associate, clinical research associate or clinical research internship related experience preferred

Previous medical device clinical trials experience preferred