Clinical Research Coordinator

Terumo•Franklin Township, NJ

About The Position

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. Job SummaryThe Clinical Research Coordinator provides administrative and operational support to the Clinical Research and Operations department staff. He/she will support multiple studies / projects across the department. The primary objective of this position is to support the execution of clinical trials by ensuring adherence to Good Documentation Practices (GDP), relevant SOPs, work instructions and study plans. In this role, the CRC may act as a liaison to vendors and/or clinical sites to oversee the quality and compliance of study documentation.Job Details/Responsibilities

Requirements

Possesses strong collaborative skills and can effectively work with cross-functional teams, site coordinators, vendors, and internal stakeholders. Demonstrate proficiency in administrative and clinical procedures, excellent written and verbal communication, and computer literacy—including Microsoft Office programs and preferred experience with EDC systems and TMF platforms like VEEVA. Detail-oriented and highly organized, capable of maintaining strict confidentiality while delivering high-quality results on time under supervision.
Bachelor’s degree in life sciences, or other related health science field, and minimum one-year general office experience required.

Nice To Haves

Clinical Research Certification (e.g. SoCRA, ACRP) and medical device/pharmaceutical experience preferred or equivalent combination of training, education and relevant experience.

Responsibilities

Participates in a variety of complex activities involved in the collection, compilation, and documentation of clinical research data used to successfully gain approval or add to clinical evidence for Terumo products.
Assists with filing inclusive of CR&O department documents, training documents, and quality review and maintenance of study electronic trial master file(s) (eTMF) to ensure audit readiness at all times
With oversight, contributes to site document collection, follow up, and communication with site coordinators to assist in site management as evidenced by complete, GDP compliant site files.
Follows study-specific processes across multiple clinical studies in accordance with appropriate regulations, Standard Operating Procedures (SOPs), work instructions, study specific protocols and plans ensuring compliance and project timelines.
Responsible to update, monitor, and disseminate status of trackers for tasks such as site selection, study start-up, TMF, and site/vendor payment etc.to ensure compliance to processes outlined in Standard Operating Procedures (SOPs).
Assist in drafting meeting minutes, distribute for review, finalize, file, and track in TMF or elsewhere as required ensuring complete documentation of meetings and action items.
Provides shipping, accountability and tracking of various study materials (e.g. binders, devices, supplies, accessories) to multiple sites, as well as internal departments ensuring all are supplied with required materials, and the study team is always aware of location and inventory levels.
May assist with invoice processing, invoice tracking, and budget tracking.
Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.