Clinical Trial Coordinator
Balt, Irvine, CA, United States
Clinical Trial Coordinator
About this opportunity: Clinical Trial Coordinator
Job 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 study invoices.
Manages study and site materials, including, but not limited to study binders, study trackers, and training documentation.
Reviews informed consents for essential elements and completes applicable documentation.
Provides support with documentation reconciliation to demonstrate that projects are run according to SOPs and regulations.
Provides 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.
Qualification Requirements
Analytical – Ability to support analysis of diverse information; collect research data; use results and experience to inform 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.
Skills
Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions; develops good interpersonal relationships with medical professionals; good presentation skills.
Written Communication – Writes clearly and informatively; presents data effectively and accurately.
Pre-requisites / Job Experience
Bachelor’s‑level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical, Pharmacy or Veterinary Sciences) preferred. 1–3 years’ experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials.
Physical Requirements
Light lifting
Moderate computer usage
Extended periods of sitting or standing
Required in‑office support in Irvine, CA (must live within driving distance of Irvine, California Balt location)
~20% domestic travel
Work Environment
May be remote with occasional requirements to travel to Balt and/or clinical research sites and/or conferences. Working conditions are normal for an office environment.
Pay Range
$80,000—$85,000 USD
Balt Group is an Equal Employment Opportunity employer.
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About this opportunity: Clinical Trial Coordinator
Job 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 study invoices.
Manages study and site materials, including, but not limited to study binders, study trackers, and training documentation.
Reviews informed consents for essential elements and completes applicable documentation.
Provides support with documentation reconciliation to demonstrate that projects are run according to SOPs and regulations.
Provides 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.
Qualification Requirements
Analytical – Ability to support analysis of diverse information; collect research data; use results and experience to inform 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.
Skills
Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions; develops good interpersonal relationships with medical professionals; good presentation skills.
Written Communication – Writes clearly and informatively; presents data effectively and accurately.
Pre-requisites / Job Experience
Bachelor’s‑level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical, Pharmacy or Veterinary Sciences) preferred. 1–3 years’ experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials.
Physical Requirements
Light lifting
Moderate computer usage
Extended periods of sitting or standing
Required in‑office support in Irvine, CA (must live within driving distance of Irvine, California Balt location)
~20% domestic travel
Work Environment
May be remote with occasional requirements to travel to Balt and/or clinical research sites and/or conferences. Working conditions are normal for an office environment.
Pay Range
$80,000—$85,000 USD
Balt Group is an Equal Employment Opportunity employer.
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