Mölnlycke, Us. - Atlanta, GA

posted 2 months ago

Full-time - Entry Level
Remote - Atlanta, GA
5,001-10,000 employees
Miscellaneous Manufacturing

About the position

Mölnlycke is seeking a Clinical Project Associate (CPA) to join our team in Atlanta, GA. This role is pivotal in supporting and contributing to the planning, conduct, and reporting of global clinical projects in accordance with applicable guidelines, laws, timelines, budget, and quality standards. The CPA will be accountable for study logistics and materials, ensuring that clinical studies are executed in compliance with established protocols. This position involves supporting clinical studies through the assignment of study site visits, which include qualification, initiation, monitoring, and close-out visits. The CPA will also be responsible for study documentation and archiving, ensuring that all necessary records are maintained accurately and are readily available for audits. In addition to these responsibilities, the CPA will support or lead project management for study delivery, ensuring that all clinical studies are executed in compliance with applicable Standard Operating Procedures (SOP), laws, and regulations. The role requires collaboration with internal and external cross-functional teams, involving stakeholders, experts, investigators, subcontractors, and authorities. The CPA will be expected to develop and maintain investigation files, manage investigational products, and oversee study logistics, including the acquisition of study supplies and documentation printing. The CPA will also take a lead role in selected tasks related to the planning, conduct, and closure of clinical projects, such as developing Clinical Investigation Plans and Clinical Investigation Reports, site selection, and vendor management. This position offers opportunities for professional growth, with the potential for development into a Clinical Project Manager (CPM) role for candidates who demonstrate drive and willingness to advance. Mölnlycke is committed to improving patient outcomes and enhancing performance at every point of care. We are looking for individuals who share our passion for patient care and are eager to contribute to our mission.

Responsibilities

  • Support and contribute to the planning, conduct, and reporting of global clinical projects.
  • Accountable for study logistics and materials.
  • Support clinical studies through assignment of study site visits, including qualification, initiation, monitoring, and close-out visits.
  • Accountable for study documentation and archiving.
  • Support or lead project management for study delivery.
  • Support or lead compliant execution of clinical studies by being skilled in applicable Standard Operating Procedures (SOP), laws, and regulations.
  • Support and improve administrative routines and procedures.
  • Develop and maintain investigation files.
  • Manage investigational products, including ordering, warehousing, shipment, and accountability.
  • Oversee study logistics, including study supplies, material acquisition, and documentation printing.
  • Take a lead role in selected tasks related to planning, conduct, and closure of clinical projects.
  • Drive operational aspects of assigned tasks, including CRO/site/lab selection, milestones, meetings, resource allocation, enrolment, and data consistency.
  • Support project budget planning and forecasting.
  • Review and maintain applicable SOP.

Requirements

  • Relevant (life science) higher education.
  • Working experience in Clinical Research (Project/Study Management, Monitoring, etc.) preferred.
  • Knowledge of clinical research methodology, GCP, and applicable regulations/laws.
  • Clinical research experience in the medical device industry preferred.
  • Strong feeling of ownership and execution.
  • Strong work ethic.
  • Problem solver with a solution-oriented mindset and good way in handling challenges and changes.
  • Accurate, resourceful, and creative personality.
  • Strong communication skills and ability to work with various stakeholders, subcontractors, and partners.
  • Comfortable working with multiple activities simultaneously and with short deadlines.
  • Experience working in cross-functional teams.
  • Fluent in English (written and spoken) and computer literate.

Nice-to-haves

  • Experience in patient monitoring.

Benefits

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible schedule
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Referral program
  • Retirement plan
  • Tuition reimbursement
  • Vision insurance
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