Responsibilities include critical evaluation of scientific documents, regulatory support, quality control, and effective communication of complex scientific information across multidisciplinary teams. This ensures trials are conducted accurately, efficiently, and in compliance with ethical and regulatory standards. Assures adherence to international Commission on Harmonization (ICH), Good Clinical Practices (GCP), and Code of Federal Regulations (CFR). Assures compliance with institutional Standard Operating Procedures (SOPs) and Policies, protocol requirements, and institutional reporting requirements. Performance of this position requires coordination and interaction among various research teams and team members.

Works side-by-side with Project Manager(s) and Project Director(s) in providing assistance to efficiently and effectively oversee the clinical trial(s) progression including sponsor’s vendor/CRO oversight, compliance with systems use, ensures accuracy of data quality for subject safety.

Communication Across Teams

• Liaises with CROs and other clinical vendors as directed to ensure deliverables are met and methods of communication are developed to facilitate efficient workflow.
• Liaises with Investigators and clinical site staff as appropriate to ensure optimal Sponsor-Site relationships as required.
• Translates complex scientific information into clear, actionable summaries for administrative and regulatory purposes.
• Participates in team meetings to discuss study progress, data trends, or emerging safety signals.

Trial Coordination & Support

• Cooperates with CROs to ensure all Monitoring Reports represent the on-site quality and action items are followed through, protocol deviations are captured as necessary and classified correctly.
• Tracks milestones, site activations, and patient recruitment metrics with an understanding of underlying clinical study design.
• Provides administrative support and meeting coordination for clinical trials in scheduling, preparing presentations, agendas, action logs and minutes. This includes advisory committee meetings and investigator meeting support, and study training.
• Sets-up, updates and maintains clinical trial-related trackers such as regulatory documents, start-up progress, screening/enrollment, study invoices/payments, project budgets and others as necessary.
• Assists in site visits such as pre-qualification, initiation, monitoring, close out, audit, etc. and activities for single and/or multi-investigational sites in accordance with designated project assignments.
• Identifies and mitigates risks, ensures the trial progresses according to timeline and regulatory expectations.

Quality Control, Project and Scientific Support

• Reviews project documents like study protocols and amendments, informed consents, adverse event reporting, and ensures trial documentation is accurately maintained.
• Assists with the development and review of clinical trial documents (e.g., study related plans like protocols, amendments, ICFs, IRB reports, CSRs, IBs, SAPs, regulatory submissions).
• Supports data integrity by cross-checking laboratory reports, pharmacokinetic/pharmacodynamic data, and adverse event summaries.
• Verifies and reviews collected trial data to confirm validity and scientific reliability, assists in reconciliation.

 Document Management

• Performs quality reviews of trials master files to ensure completeness and audit-readiness.
• When on clinical site, reviews investigator’s study file to ensure that all documents are ready for an audit and/or site inspection and discusses pertinent study materials retention and publication policy.

Competencies:

Education & Experience:

Bachelor's degree in Science/Health related field (i.e. Nursing, Medical Terminology, Biology, Pharmacy or Biochemistry) or equivalent education, or experience.

Three to five years of professional experience in clinical research or the pharmaceutical industry.

Good written and verbal communication skills, including public speaking; ability to establish and maintain internal and external working relationships. 

Ability to work independently with limited supervision and within a team environment. 

Computer literate at the intermediate level of MS Office Suite application software. 

Knowledge of clinical trial operations, ICH-GCP guidelines, FDA regulatory requirements (CFRs and GCPs).

Judgment / Decision Making:

• Under general direction with periodic review of assignments.
• Duties performed within a federally regulated environment.
• Must be able to work independently with limited supervision and with other team members.
• Executes assigned work efficiently and adheres to project timelines.
• Must be able to recognize clinical values and abstract data from source documents and possess analytical ability to identify data or patient safety issues.
• Must have a thorough understanding of clinical trial protocols, data collection requirements, and methodologies.

Work Environment:

Air-conditioned office environment. Majority of time spent sitting at desk, operating computer and proofreading documents. Occasional exposure to human source products when at study sites. Up to 10% travel may be expected.

Physical Demands:

Visual acuity and manual dexterity required to proofread high volume of documents and operate computer.