Jobs at CenExel

Manages clinical trial contract and budget negotiations with sponsors, CROs, vendors, and research sites. Prepares and evaluates study budgets, cost estimates, amendments, and financial viability analyses; supports site start-up, feasibility, and RFP activities. Collaborates with Clinical Operations, Business Development, Finance, and legal stakeholders while ensuring compliance with protocols, SOPs, GCP, IRB, FDA, and company requirements. Supervises personnel and provides reports and process improvement recommendations.

Conduct and oversee Phase I–IV clinical trials as Principal Investigator, ensuring protocol compliance, participant safety, data integrity, informed consent, regulatory reporting, staff training, and appropriate delegation. Evaluate participants, investigational therapy responses, and adverse events while collaborating with study teams, sponsors, medical personnel, and regulators. Manage research budgets, personnel, compliance, and collaborative relationships. Maintain medical licensure, board certification, and required clinical research credentials.

Supports Clinical Research Coordinators in conducting Phase I–IV clinical trials. Responsibilities include maintaining patient charts, preparing participant visits, managing study supplies, entering clinical data, resolving queries, assisting with participant assessments, communicating with participants and vendors, scheduling, and supporting monitoring visits while following ICH, GCP, protocol, and site requirements.

Supports clinical trial laboratory operations by preparing collection materials, collecting and processing samples according to protocols, maintaining temperature and inventory logs, monitoring storage conditions, managing chain-of-custody documentation, and packing study materials for storage or shipment. The role requires laboratory procedure knowledge, accurate documentation, inventory management, and availability for weekend work.

Regulatory Coordinator I prepares, submits, maintains, and archives regulatory documents for clinical trials. Responsibilities include coordinating IRB and sponsor submissions, tracking investigator and staff credentials, managing regulatory binders, supporting monitor visits, audits, and inspections, preparing safety and protocol deviation reports, onboarding investigators, and ensuring compliance with FDA regulations, ICH GCP, SOPs, and study protocols.

Supports Clinical Research Coordinators in conducting clinical trials by maintaining patient charts, preparing participant visits, managing study supplies, entering clinical data, resolving queries, conducting basic assessments, communicating with participants and vendors, and completing clerical and monitoring-visit tasks. The role requires adherence to ICH, GCP, protocol, and site guidelines in an on-site clinical research environment.

Assists with coordinating Phase I–IV clinical trials from initiation through completion. Responsibilities include organizing study information, scheduling data collection, documenting adverse events and protocol deviations, maintaining regulatory compliance, reporting research data, educating participants, coordinating sponsor supplies, and performing protocol-required safety and efficacy assessments such as vital signs, EKGs, and blood draws.

Supports laboratory operations for clinical trials by preparing collection materials, obtaining and processing samples according to protocol, maintaining temperature and chain-of-custody logs, managing inventories, and packaging study materials for storage or shipment. The role assists with site preparation, documents laboratory activities, monitors freezer and refrigerator conditions, and works full-time in a clinic and laboratory environment, including weekends.

Oversees daily clinical trial activities, including participant nursing care, protocol execution, eligibility screening, informed consent, specimen handling, adverse event reporting, documentation, investigational medication coordination, and sponsor communication. Maintains study records, supplies, drug accountability, regulatory compliance, and quality standards while supporting recruitment and clinical assessments.

Supports Clinical Research Coordinators with protocol-specific clinical trial activities, including maintaining patient charts, preparing participant visits, managing study supplies, entering clinical data, resolving queries, assisting with basic assessments, communicating with participants and vendors, scheduling, and supporting monitoring visits. Ensures adherence to ICH, GCP, study protocols, and site procedures while completing clerical and administrative responsibilities.

Assists regulatory staff with maintaining, organizing, tracking, and filing clinical trial and training documents. Supports submissions to regulatory agencies, obtains investigator signatures and CVs, distributes updated study materials, maintains Clinical Conductor records, and coordinates regulatory issues with sponsors, CROs, investigators, and clinical trial personnel. Ensures compliance with protocols, site SOPs, IRB requirements, ICH GCP, FDA guidelines, and applicable best practices.

Supports Clinical Research Coordinators with protocol-specific clinical trial activities, including maintaining patient charts, preparing participant visits, managing study supplies, entering clinical data, resolving queries, conducting basic assessments, communicating with participants and vendors, scheduling, and supporting monitoring visits while adhering to ICH, GCP, protocol, and site guidelines.

Oversee the clinical research nursing department and patient care technicians. Responsibilities include scheduling, delegation, performance management, supervising direct participant care, staff training, protocol education, safety oversight, competency reviews, and coordination with management to ensure efficient, high-quality clinical trials.

Assists with coordinating clinical trials from initiation through completion while adhering to ICH, GCP, protocols, and regulations. Responsibilities include scheduling data collection, organizing trial information, documenting adverse events and protocol deviations, reporting research data, supporting regulatory activities, educating participants, coordinating sponsor supplies, and performing protocol-required safety and efficacy assessments such as vital signs, EKGs, and blood draws.

Coordinates clinical trial activities from initiation through completion while adhering to ICH, GCP, protocols, and regulatory requirements. Responsibilities include managing participant involvement, organizing research data, scheduling assessments, documenting adverse events and protocol deviations, maintaining compliance reports, supporting regulatory activities, coordinating supplies, educating participants, and performing safety and efficacy assessments such as vital signs, EKGs, and blood draws.

Supports clinical research quality assurance programs by reviewing monitoring reports, protocol deviations, study records, laboratory reports, and source documentation. Conducts sampling-based quality reviews to ensure compliance with protocols, SOPs, ICH GCP, FDA regulations, and IRB guidelines. Assists with audit and FDA inspection preparation, trend analysis, site initiation visits, and implementation of quality policies. This is an on-site office role requiring strong organization, communication, attention to detail, and knowledge of clinical research regulations.

Coordinates regulatory documentation for Phase I–IV clinical trials, including study start-up submissions, protocol amendments, informed consents, FDA forms, IRB materials, logs, licenses, and reports. Serves as liaison among investigators, sites, sponsors, CROs, and IRBs; tracks staff credentials, coordinates vendor contracts, supports SOP training, drafts procedures, and archives trial records in compliance with FDA guidelines, ICH GCP, and applicable regulations.

Provide nursing care and oversee daily clinical study activities at a research site. Duties include executing protocols, screening and consenting subjects, collecting and processing specimens, administering investigational medications, documenting case report forms, monitoring vitals and lab results, reporting adverse events, maintaining study logs and supplies, supporting sponsor visits, and assisting with QA activities.

Perform clinical and neurocognitive assessments and rating-scale interviews per protocol to confirm diagnoses and evaluate cognitive, behavioral, and functional status; maintain data integrity, complete study trainings, support consensus rounds, and follow GCP/FDA/ICH and site SOPs.

Prepare and serve meals to clinical research patients, set up trays per requirements, assist with food preparation and beverage service, clean and restock dining and kitchen areas, transport dishes and trash, and perform other assigned duties to maintain sanitation and meal delivery.