The Clinical Data Coordinator will participate in various clinical data management activities to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed and reported clearly, accurately and securely.
Responsibilities
Provides general data management support to the project team, sponsor and external vendors, as needed.
Supports Lead Data Manager in Data Review
Data Reconciliation
Discrepancy Management
Maintenance of Study Metrics; Monitoring study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.
Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs.
Responsibilities
Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan
Oversees project-related education of investigators, study site personnel, and AbbVie study staff
Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned
Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents
Requirements
Medical Doctor (M.D.)
Doctor of Osteopathy (D.O.)
non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment
Provides support to business units within the organization, working closely with investigator sites regarding data discrepancies and study questions to ensure accurate execution of protocols.
Responsibilities
Provides support to most business units within the organization
Works closely with investigator sites regarding data discrepancies and or general study questions
Supports the overall performance, education, and escalation of study questions or data discrepancies
Resolves issues that arise during specimen accessioning to ensure specimen logging is accurate
Places calls to investigator sites regarding sponsor alerts, voice alert values, and critical values
Provide statistical input into the clinical development of drugs for treatment of cancer
Work with the clinical team in designing clinical studies, leading/authoring the statistical analysis plan, conducting the statistical analysis, and providing statistical input to the clinical study report
Research Coordinator II
University of Southern California · Posted Nov 5, 2026
The Senior In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements.
Responsibilities
Assisting with operational activities supporting site management and monitoring of clinical studies/trials
Triage questions or requests from site staff using study protocol, site monitoring plan, and study manuals
Independently collects, reviews, maintains, and tracks required essential documents
Perform upload of essential documents into the trial master file
Independently communicates and coordinates effectively with internal project staff and site staff
Requirements
Bachelor's Degree in Scientific discipline
Nice to have: Directly applicable work experience in lieu of a degree
Provide input in the preparation of scientific presentations and manuscripts
Participate in process improvement, training, standards development and enhancing statistical technical expertise
Liaise with other statisticians within the organization, building working relationships with therapeutic area leaders, internal SAS programmers, clinical trial managers, and personnel from regulatory affairs, medical writing, and other disciplines as needed
Requirements
PhD in Statistics
Master’s Degree in related field with at least six years of clinical data analysis experience
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