Clinical Trial Coordinator

BALT Group•Irvine, CA

22h•Hybrid

About The Position

Balt is a rapidly growing pioneer in the medical device field, with 45 years of experience in developing elegant medical devices. They have a global presence with 13 offices in 11 countries and are expanding their innovation into the peripheral vascular space. This role is an opportunity to join a passionate team dedicated to making a difference in patients' lives and empowering physicians to save lives. The company emphasizes pride, recognition, respect, and a multicultural community as key aspects of the employee experience.

Requirements

Analytical - Ability to support analysis of diverse information; collects research data; uses results and experience to inform the appropriate functions regarding product specific direction (as appropriate)
Design - Generates creative solutions; demonstrates attention to detail
Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations
Organizational Support - Supports organization's goals and values
Adaptability & Dependability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments.
Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas
Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. Independently motivated.
Demonstrated ability to manage multiple global complex clinical projects
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions. Ability to develop good interpersonal relationships with medical professionals. Good presentation skills.
Written Communication - Writes clearly and informatively; presents data effectively and accurately.
Bachelor’s-level degree required.
1-3 years’ experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials.

Nice To Haves

Degree in science/health related field (e.g., Biology, Nursing, Biomedical, Pharmacy or Veterinary Sciences) preferred.

Responsibilities

Provides Trial Management Filing (TMF) system support, including document inspection, filing, and auditing.
Supports study budget negotiation and contract finalization related to any study providers, scientific committee members and investigator sites, and other contracts as required.
Serves as key facilitator and liaison for shipping, receiving, and management of study devices, and other equipment.
Responsible for reviewing, processing, and tracking of study invoices.
Manages study and site materials, including, but not limited to study binders, study trackers, training documentation.
Reviews informed consents for essential elements and completes applicable documentation.
Provide support with documentation reconciliation to demonstrate that projects are run according to SOPs and regulations.
Provide feedback for processes which need updating and documenting to the direct line manager.
Through matrix reporting, responsible for supporting project teams both administratively and technically as appropriate.
May provide study monitoring support to study sites, as needed.
Performs other duties as required.