Saratoga Ascend

Clinical Research

• Design and develop case report forms and data collection instruments
• Configure, validate and test study databases, including edit checks and user access controls
• Clean data, manage discrepancies and queries, and reconcile safety and external data
• Produce data extracts, listings and documentation for analysis, monitoring and DSMB review
• Prepare data management plans, data dictionaries and database lock procedures
• Support NIH or FDA-regulated clinical research programs
• Work in a multidisciplinary team alongside Government clinical investigators, regulatory staff and program officials

Explore Clinical Data Manager – REDCap, CTDB at Saratoga Ascend. Review requirements and application details.

Clinical Data Manager – REDCap, CTDB

• Oversee multi-site or complex clinical trials from start-up through close-out
• Manage task-order or contract deliverables, schedules, budgets and risks
• Coordinate clinical operations, monitoring, data management, regulatory and quality functions
• Provide quality assurance oversight and track corrective actions
• Support staffing and transition planning
• Lead multidisciplinary teams and coordinate with Government clinical investigators, regulatory staff and program officials
• Provide stakeholder communication and Government reporting

Explore Senior Clinical Research Project, Trial Manager at Saratoga Ascend. Review requirements and application details.

Senior Clinical Research Project, Trial Manager

• Conduct site initiation, interim monitoring and close-out visits, both on-site and remotely
• Perform source document verification, informed consent review, and protocol and GCP compliance assessments
• Review adverse event and serious adverse event documentation and reporting
• Manage investigational product accountability, storage and reconciliation
• Write monitoring reports, identify deficiencies, and develop and track corrective and preventive actions (CAPA)
• Support NIH- or FDA-regulated clinical research programs
• Work alongside Government clinical investigators, regulatory staff and program officials in a multidisciplinary team environment
• Travel as required

Explore Senior CRA, Clinical Trial Monitor at Saratoga Ascend. Review requirements and application details.

Senior CRA, Clinical Trial Monitor

• Review and medically assess adverse events and serious adverse events, including causality and expectedness
• Conduct ongoing review of safety data trends, eligibility questions, and protocol deviations with the study team
• Consult on safety reporting to FDA, IRBs, and DSMBs
• Provide timely, ongoing consultation to investigators and study staff
• Support NIH or FDA-regulated clinical research programs
• Work alongside Government clinical investigators, regulatory staff, and program officials in a multidisciplinary team environment

Explore Medical Monitor, Clinical Safety Professional at Saratoga Ascend. Review requirements and application details.

Medical Monitor, Clinical Safety Professional

Compliance

• Prepare and review IND/IDE applications, protocol amendments, information amendments, and annual reports
• Prepare IND safety reports and other expedited safety submissions
• Support FDA meetings, including pre-IND and other formal interactions
• Manage regulatory correspondence
• Review and maintain regulatory files and essential documents
• Maintain submission trackers
• Work in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff, and program officials

Explore Senior IND/IDE Regulatory Affairs Specialist at Saratoga Ascend. Review requirements and application details.

Senior IND/IDE Regulatory Affairs Specialist

• Support clinical studies as a senior clinical/trial biostatistician
• Design clinical studies, including small-population and early-phase studies
• Develop statistical analysis plans and randomization schemes
• Perform power and sample size calculations
• Conduct interim and final analyses
• Produce tables, listings and figures for DSMB reviews and regulatory submissions
• Support preclinical studies
• Contribute to protocols, reports and manuscripts
• Support NIH- or FDA-regulated clinical research programs
• Work alongside Government clinical investigators, regulatory staff and program officials in a multidisciplinary team

Explore Senior Clinical, Trial Biostatistician at Saratoga Ascend. Review requirements and application details.

Senior Clinical, Trial Biostatistician

Executive Assistant

• Support data and safety monitoring boards, review committees or similar oversight bodies
• Schedule meetings, develop agendas and assemble meeting materials
• Record accurate, timely minutes and track action items and recommendations
• Maintain conflict-of-interest disclosures, member rosters and committee records
• Coordinate preparation of open and closed session reports with statisticians and study teams
• Serve as the communication link between DSMB members, investigators and NHGRI staff
• Handle confidential information with discretion and attention to detail
• Work alongside Government clinical investigators, regulatory staff and program officials in a multidisciplinary team

Explore Executive Secretary / Committee Coordinator at Saratoga Ascend. Review requirements and application details.

Executive Secretary / Committee Coordinator

• Develop and maintain monitoring SOPs and quality management documents
• Conduct quality review of monitoring reports, essential documents and regulatory files
• Track and verify CAPA and the effectiveness of corrective actions
• Conduct or support internal audits and inspection readiness activities
• Deliver GCP and protocol training for clinical research staff

Explore Clinical Research QA Specialist at Saratoga Ascend. Review requirements and application details.

Clinical Research QA Specialist

• Administer, configure, and migrate REDCap, CTDB, and other clinical research applications
• Manage approved hosting environments, including backup, access control, and system validation
• Support secure handling and transfer of genomic and clinical data
• Develop and maintain scripts and data integrations using technologies such as Python, R, and SQL
• Produce technical documentation and provide user support
• Support NIH or FDA-regulated clinical research programs
• Work alongside Government clinical investigators, regulatory staff, and program officials in a multidisciplinary team environment

Explore Clinical Research Systems – Bioinformatics Specialist at Saratoga Ascend. Review requirements and application details.

Clinical Research Systems – Bioinformatics Specialist

Statistician

• Analyze behavioral, social science or survey data
• Apply survey design, sampling and weighting methods
• Conduct advanced multilevel, structural equation and longitudinal modeling
• Develop scales and perform psychometric validation
• Handle missing data and complex measurement issues
• Provide statistical consultation to investigators
• Support manuscript preparation
• Support NIH or FDA-regulated clinical research programs
• Work in a multidisciplinary team alongside Government clinical investigators, regulatory staff and program officials

Explore Senior Social and Behavioral Research Statistician at Saratoga Ascend. Review requirements and application details.

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