Patient Recruitment & Clinical Research Associate

We are seeking a motivated and enthusiastic Patient Recruitment & Clinical Research Associate with prior experience in diabetic foot ulcer (DFU) studies. In this exciting and highly visible position at Piomic Medical, you will play a vital project management role in our US clinical trials, beginning with our current Phase III Investigational Device Exemption (IDE) DFU clinical study.

This position offers a rewarding opportunity to work in a fast-paced startup environment for a multinational medical device company, headquartered in Zurich, Switzerland with a U.S. subsidiary in the Chicago metro area. You will engage in a variety of clinical trial activities that foster professional development and personal fulfillment, while advancing the Company’s leadership position as an innovator in the wound healing space. The company’s core technology platform, COMS™ One therapy, received CE Mark Approval in 2020 and is currently treating patients with lower extremity ulcers in Europe.

Tasks

Patient Recruitment Responsibilities

• Work closely with clinical team members to develop and fulfill patient recruitment and retention strategies for assigned protocols.
• Propose new patient recruitment strategies, including those that can be performed by Company personnel, independent of established patient recruitment vendors.
• Develop a patient identification strategy, journey map and experience plan that collectively increase patient recruitment and retention.
• Manage workflow and internal review of patient facing materials between internal and external stakeholders.
• Monitor success of recruitment programs using agreed upon metrics/KPIs, prepare data-based reports, and make recommendations for improvements.
• Contact physician referral sources to generate study awareness and request patient referrals.
• Collect and relay enrollment and retention best practices to all study sites and other stakeholders.
• Contribute to vetting and recommending patient recruitment vendors and related third parties.
• Complete other tasks as assigned by supervisor.
  
  
  

Clinical Research (CRA) Responsibilities

• Collaborate in the development and execution of clinical strategies to support US trials.
• Support all stages of clinical studies, overseeing study startup activities and maintaining involvement throughout the trial and during closeout activities.
• Support the negotiation of contracts and budgets.
• Provide training to study staff on protocol, device handling, proper data collection, and safety event reporting.
• Perform an ongoing review and reconciliation of the data collected by the research sites.
• Participate and occasionally lead regularly scheduled update calls with study sites.
• Participate in weekly study progress meetings with CRO and Company personnel.
• Support investigational product controls, inventory tracking, and investigational device shipment and return procedures.
• Collaborate with internal staff and CRO to create necessary study materials, including worksheets, CRFs, study logs, reports, and tracking tools.
• Complete other tasks as assigned by supervisor.
  
  
  

Requirements

Education Requirements and Qualifications

• Bachelor's degree preferred, associate’s degree a minimum
• Minimum 3 years’ experience working within patient recruitment/retention and clinical trials
• Diabetic foot ulcer trial experience required
• Proven results generating successful patient recruitment strategies in a clinical research department or for a patient recruitment organization
• Experience supporting research staff at clinical study sites/hospitals
• Medical device experience preferred
• Good understanding of Good Clinical Practice guidelines
• Excellent oral, written and interpersonal communication skills
• Strong customer focus, presentation, and project management skills
• Strong sense of urgency to meet timelines and project deliverables
• Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while remaining flexible to changing conditions
• Global reporting experience preferred
• Willing to travel up to 50%
• Part-time candidates will be considered (minimum 20 hours/week)
  
  
  

Benefits

We offer a competitive salary and benefits package, plus a dynamic and collaborative work environment.

We welcome you to apply for this exciting opportunity at Piomic Medical. Your contributions will have a direct and meaningful impact on the success of our first U.S. clinical trial, and in turn, on our entry into the U.S. advanced wound care market.

Applications will be reviewed in a timely manner. Candidates selected for interviews will be contacted for scheduling, and all candidates will be notified of their application status. We hope to fill this position within 4-6 weeks. Thank you for considering Piomic Medical for your next role.