Responsible for clinical study site maintenance, data and source documentation collection, as well as field monitoring for clinical trials being conducted to support applications for research, marketing permits, postmarket and outcomes studies being conducted on devices regulated by FDA or other regulatory bodies. Clinical study development responsibilities include literature research, protocol composition, case report form design, recommendations for investigators, budgeting, site selection and training, and study monitoring plans. Additional clinical study responsibilities include management of study sites, CROs and data analysis reports as well as the coordinator of resultant publications and presentations.
Principal Duties and Responsibilities
In collaboration with strategy, develops protocols, Case Report Forms and training presentations as needed in conjunction with the post-market surveillance team, biostatisticians and the data management team.
Maintains the clinical study trial master file.
With minimal assistance, conducts clinical site visits including site selection, site initiation and training as well as general oversight(to evaluate the performance/compliance levels of site and takes appropriate action necessary to resolve any problems of noncompliance), as well as re-training of new investigators and coordinators at each investigational site. Performs interim monitoring visits according to Zimmer Biomet clinical procedures. Coordinates study payments and reimbursements per department processes.
Tracks study progress and adherence to protocol, as well as data submission, deviations and discrepancies.
Communicates with sites on a regular basis, sending updates on current status of study enrollment and follow-up, and assisting with resolution of problems.
Ensures adverse events and product complaints are captured and reported as outlined in Zimmer Biomet policies and procedures. Participates in product investigations when required.
Provides oversight for vendors being used in the conduct of assigned studies.
May assist with procedure development.
Develops annual budgets for assigned study(ies).
Drives innovation through embracing diversity and change.
Takes accountability and achieves Results.
Sets the Example and thereby shapes the culture.
Expected Areas of Competence
Knowledge of applicable regulations governing clinical studies and Good Clinical Practice guidelines.
Possess the ability to use sound judgment independently on issues related to studies.
Working knowledge of Microsoft Office Suite, including Word, Excel and Powerpoint.
Must possess strong written and verbal communication skills.
Must be detail-oriented and have a thorough knowledge of principles and procedures necessary to insure data quality and integrity.
Must be capable of handling confidential information.
Must be able to work independently and under pressure to meet critical deadlines.
A Bachelor’s Degree required, preferably in the health, life sciences, or engineering disciplines.