Senior Clinical Research Consultant (Contractor)

Position overview

United Research Group is seeking an experienced Senior Clinical Research Consultant to provide specialized clinical monitoring, operational oversight, and regulatory compliance support across clinical research programs. The consultant will collaborate with sponsors, CROs, Principal Investigators, and clinical research site teams to support high-quality study execution, participant safety, data integrity, and regulatory inspection readiness. The ideal candidate will demonstrate advanced expertise in clinical trial monitoring, site management, risk identification, and the implementation of effective operational strategies throughout the clinical study lifecycle.

Responsibilities

• Conduct and oversee site initiation, interim monitoring, and closeout activities across assigned clinical research sites.
• Ensure compliance with ICH-GCP, FDA regulations, study protocols, sponsor requirements, and applicable SOPs.
• Perform source data verification (SDV) and source data review (SDR) to support accurate, complete, and reliable clinical data.
• Review essential regulatory documentation, informed consent records, and investigator site files.
• Evaluate investigational product accountability, handling, and reconciliation records where applicable.
• Review adverse events, serious adverse events, protocol deviations, and related safety documentation.
• Collaborate with sponsors, CROs, investigators, and site teams to resolve operational challenges and monitoring findings.
• Evaluate recruitment and retention performance and recommend strategies to support enrollment objectives.
• Provide training and mentorship on protocol requirements, GCP, SOPs, and clinical research best practices.
• Identify compliance risks, recommend mitigation measures, and support CAPA implementation.
• Support study milestones, operational efficiency, and regulatory inspection readiness.

Qualifications

• Bachelor's degree in life sciences, nursing, healthcare, or a related discipline; equivalent relevant experience may be considered.
• Extensive clinical research experience, preferably in senior-level monitoring, site management, or clinical operations consulting.
• Strong knowledge of ICH-GCP, FDA regulations, clinical trial protocols, and regulatory compliance.
• Experience conducting SIVs, IMVs, and COVs.
• Demonstrated expertise in SDV, SDR, regulatory documentation, protocol deviation management, and safety review.
• Experience collaborating with sponsors, CROs, investigators, and research site personnel.
• Familiarity with EDC, CTMS, eTMF, and related clinical research systems.
• Strong analytical, communication, organizational, and independent consulting skills.

Preferred experience

• Phase I–IV clinical research experience.
• Risk-based monitoring and remote monitoring experience.
• Regulatory inspection, audit, and CAPA support.
• Training and mentorship of clinical research personnel.