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Clinical Research Specialist_
3 months ago
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging. **What You Can Expect** In consultation and collaboration with the Clinical Project Lead or Clinical Manager, you will be able to oversee and support the conduct of clinical studies including but not limited to: study management tasks of site qualification, contract and budget negotiations, preparation and presentation of committee documentation, study initiation and management including pre-monitoring, remote and on-site monitoring, tracking, organizing, filing and maintaining study related documents, maintaining IRB approvals in accordance with applicable compliance regulations and standards (i.e. GCP, ICH, ISO, FDA and MDR). Excellent communication skills needed to provide excellent customer service to surgeon investigators and coordinators as well as internal Zimmer Biomet divisions. **How You'll Create Impact** **_Clinical Study Site Management_** _In consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:_ + Identify and assess suitability of clinical study sites and investigators + Prepare documentation and present nominations of site/investigator to CRRC for approval + Finalize budget and negotiate study contract with sites + Support and coordinate with PI on IRB/EC review + Prepare site subject binders, study visit documents and PowerPoint presentations + Resolve site issues and data discrepancies / queries with investigators and site coordinators + Conduct site visits (SQV, IMV, COV) as required per Monitoring Plan to perform source data/document verification + Complete clinical study site visit reports + Prepare and distribute Patient Due Listings as appropriate + Clinical study product and material accountability + Close out clinical study sites on completion of the study + Will primarily be responsible for non-regulated clinical studies, but may be introduced to regulated study activities as appropriate **How You'll Create Impact** **_Clinical Project Management_** _In consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:_ + Collaborate with Clinical Strategy team to identify product clinical needs + Create study protocol, study synopsis/summary, CRF and Informed Consents documents + Prepare for CIRC review and approval + Establish clinical database and CRF discrepancy parameters for each study with close collaboration of the Data Management team + Maintain study requirements for posting to clinicaltrials.gov + Maintain and update Clinical Trials Management System (CTMS) as needed + Maintain completeness of site documents in trial master file + Able to assist in the creation and maintenance of the study annual budget + Able to complete a literature search and international registry review to assess product performance + Review and provide input on Post Market Plan, Post Market Reports and other study reports as necessary + Oversee Investigator Initiated Research (IIR) projects as assigned + Able to create and edit a study report (annual or ad hoc) as needed + Assist other team member participating in the cross-training opportunities with study-related activities **How You'll Create Impact** **_Process Management_** _In consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:_ + Works with team members to identify process improvements + Participate in regional and global process improvement initiatives + Maintain standard operating procedures + Actively participates in departmental and business unit meetings and scheduled activities + Willing to assist and mentor other team members + Ability to effectively identify and resolve conflicts and disagreements regarding clinical research matters + Impacts project teams and business units through quality work and leadership of projects or portions of projects + Keep current on learning requirements without lapse or overdue assignments **What Makes You Stand Out** + Works well as part of a team + Positive attitude + Self-awareness of the impact of actions on others + Willingness to learn and progress + Basic command of English (written and oral) language + Understanding and willingness to follow Zimmer Biomet policies, procedures, standard operating procedures, and work instructions + Basic understanding and willingness to comply with Regional and Global regulations (ICH/FDA/MDR) + Basic understanding of medical terminology + Ability to prioritize assignments, manage time efficiently and assist in project oversight to meet established deadlines + Develop competencies with CTMS, Medispend, electronic data capture systems and other electronic systems used for clinical research + Proficient in Microsoft Office including Word, Excel, and PowerPoint + Ability to multi-task in fast paced environment is essential. + Must be able to perform in a diverse cross-functional team environment + Initiates and exchanges best practices with other team members and business partners + Able to adapt behaviors and attitude to improve performance of the team and to have a positive effect on the outcome of the project + Development of project management skills **Your Background** + Bachelor's Degree or postgraduate degree or in nursing, life sciences, engineering or medical sciences + Clinical research experience (sponsor) or clinical study management (site) (3 – 5 year) + Established knowledge on Good Clinical Practice (GCP) and local government related guidelines / regulations **Travel Expectations** Up to 35-50% EOE/M/F/Vet/Disability
