Senior Specialist, Study Training Compliance & DoA Matrix Management

Jobgether SRL; United States; Remote; USD 60,000 - 80,000; Full time

Benefits offered by this job

Fully remote within the United States

Medical, dental, vision coverage

401(k) retirement plan with company 60

PTO and holidays

HSA/FSA options and employer contrib.

Job summary

Jobgether SRL seeks a Senior Specialist to oversee study training compliance and DoA matrix management from a fully remote position in the United States. The role focuses on ensuring audit-ready training records across a portfolio of clinical studies and coordinating DoA matrices with protocol timelines.

You will work with internal teams, sites, sponsors, and vendors to strengthen documentation quality, support regulatory readiness, and optimize compliance workflows in a fast-paced environment.

Qualifications

• Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or related field preferred.
• 3–5 years in central support, clinical operations, or clinical research compliance in regulated environment.
• Experience supporting training compliance workflows and DoA matrix coordination.
• Knowledge of ICH-GCP, SOPs, sponsor requirements; audit-ready docs.
• Experience with eISF platforms (Florence) and CTMS; sponsor portals.
• Proficient with MS Office and compliance tracking tools.

Responsibilities

• Monitor training completion across studies ensuring compliance with ICH-GCP, SOPs and sponsor standards.
• Verify training accuracy for start-up, transitions, and milestones.
• Maintain training records and certificates in eISF and internal systems.
• Coordinate DoA matrices in line with protocol and timelines.
• Ensure staff roles align with delegated responsibilities; raise gaps.
• Assist with audits, sponsor inspections, and monitoring visits.
• Serve as point of contact for training compliance questions and deadlines.
• Coordinate with sponsors, vendors, and operations to resolve issues.
• Contribute to training plans, trackers, and SOPs for consistency.
• Identify process improvements and develop guidance material.

Skills

Training compliance

DoA matrix coordination

Documentation management

ICH-GCP

SOPs

eISF Florence

CTMS

MS Office

Attention to detail

Remote collaboration

Education

Bachelor's degree in Life Sciences/Health Administration/Clinical Research

Tools

Florence

CTMS

Clinical Conductor

Sponsor portals

SharePoint

Job description

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Specialist, Study Training Compliance & DoA Matrix Management based in the United States.

This role offers an opportunity to strengthen training compliance and documentation quality across a portfolio of clinical research studies in a regulated, fast-paced environment. As a key contributor to clinical operations, you will coordinate study training requirements, oversee Delegation of Authority (DoA) matrix management, and help ensure study teams are prepared for activation and ongoing execution. You will collaborate with internal stakeholders, site staff, sponsors, and vendors to maintain accurate, complete, and audit-ready records. By identifying documentation gaps and improving compliance workflows, you will support operational consistency and adherence to regulatory standards. This fully remote position is suited to an experienced clinical research professional who combines strong organizational skills with attention to detail and a proactive approach to problem-solving.

Accountabilities

• Monitor and coordinate training completion across multiple clinical studies, ensuring compliance with study-specific requirements, ICH-GCP, standard operating procedures (SOPs), and sponsor documentation standards.
• Verify training accuracy and suitability for assigned roles during study start-up, transitions, and other key study milestones.
• Maintain complete, accurate, and up-to-date training records and certificates within electronic Investigator Site File (eISF) platforms and other internal systems.
• Coordinate the creation, review, approval, and ongoing updates of Delegation of Authority (DoA) matrices in line with protocol requirements and study timelines.
• Confirm that training status and staff roles align with delegated study responsibilities, identifying and escalating gaps before study activation.
• Support audit readiness by preparing documentation, responding to document requests, and assisting with internal audits, sponsor inspections, and monitoring visits.
• Serve as a point of contact for training compliance and delegation documentation questions, providing guidance to internal teams and site staff on requirements and deadlines.
• Partner with clinical operations teams, sponsors, vendors, and other stakeholders to coordinate compliance activities and resolve documentation challenges.
• Contribute to study-specific training plans, compliance trackers, and standardized tools that improve visibility, consistency, and operational efficiency.
• Identify process improvement opportunities and assist in developing and refining guidance materials, trackers, and internal SOPs.
• Participate in meetings, share subject matter expertise, and perform additional duties as assigned.

Requirements

• Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred.
• Three to five years of experience in central support, clinical operations, clinical research compliance, or a related function, ideally within a regulated research environment.
• Demonstrated experience supporting or leading training compliance workflows, DoA matrix coordination, and documentation management across multiple clinical studies.
• Strong understanding of clinical research operations, training documentation, regulatory requirements, and quality-driven processes.
• Familiarity with ICH-GCP principles, SOPs, sponsor requirements, and maintaining audit-ready documentation across clinical trials.
• Experience with electronic Investigator Site File (eISF) platforms, particularly Florence, Clinical Trial Management Systems (CTMS), Clinical Conductor, sponsor portals, and other training or compliance systems is strongly preferred.
• Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and SharePoint, as well as compliance tracking databases and tools.
• Excellent organizational, planning, and tracking skills, with a high level of attention to detail and documentation accuracy.
• Ability to manage multiple complex assignments independently, prioritize competing deadlines, identify compliance gaps, and resolve issues proactively.
• Strong written and verbal communication skills, with the ability to collaborate effectively with internal teams, clinical site staff, sponsors, and vendors.
• Comfortable working independently in a remote environment while contributing to cross-functional priorities and continuous process improvement.
• Authorized to work in the United States without requiring current or future visa sponsorship.

Benefits

• Salary: $60,000–$80,000 USD per year for full-time team members.
• Remote flexibility: Fully remote work within the United States, with less than 10% travel expected and occasional planned trips.
• Paid time off: Paid time off (PTO) and company-paid holidays.
• Healthcare coverage: Medical, dental, and vision insurance plan options with 100% of premiums paid by the employer.
• Health savings options: Health Savings Account (HSA) and Flexible Spending Account (FSA) options, plus biweekly employer contributions to the HSA.
• Disability coverage: Company-paid short-term and long-term disability insurance.
• Retirement savings: 401(k) retirement plan with a company match.