Study Start-Up Specialist (SSU) (3993)

Job DetailsJob Location: Corporate - Karachi (KHI) - Karachi, Sindh 75600Position Type: 1099 Education Level: Associate's DegreeTravel Percentage: NegligibleJob Shift: AnyJob Category: ResearchThe Study Start-Up Specialist (SSU) is responsible for supporting operational study startup activities across the clinical research network from study award through site activation. This role assists with startup coordination, document tracking, milestone follow-up, system updates, and communication between internal teams, sponsors, CROs, and research sites to support efficient and compliant study activation. The SSU Specialist works closely with SSU leadership, Regulatory, Clinical Operations, Clinical Data, sponsors, CROs, investigators, and site teams to support startup deliverables, dependencies, and timelines while maintaining workflow organization and operational consistency across assigned studies. This role focuses on operational execution, startup follow-up, documentation support, startup tracking, and maintaining timely communication throughout the startup lifecycle.

DUTIES & RESPONSIBILITIES

1. Study Start-Up Coordination & Activation Support

Support startup activities across assigned studies and network sites from study award through activation
Assist with tracking startup timelines, deliverables, milestones, and outstanding action items
Maintain startup trackers, activation logs, and operational documentation
Coordinate follow-up on pending startup tasks, approvals, and documentation requirements
Support the timely progression of startup activities according to sponsor expectations and internal timelines
Assist with scheduling startup meetings, activation discussions, and sponsor calls as needed
Support activation readiness activities and operational startup preparation
Escalate startup delays, missing items, or workflow barriers to SSU leadership appropriately

1. Cross-Functional Startup Coordination

Coordinate with Regulatory, Clinical Operations, Clinical Data, PMO, sponsors, CROs, and site teams regarding startup activities
Provide startup status updates and operational follow-up communication to relevant stakeholders
Support the collection, organization, and follow-up of startup-related documentation and deliverables
Assist with sponsor, CRO, and site communications related to startup timelines and requirements
Follow up on startup action items and operational dependencies to support timely completion

1. Startup Tracking, Reporting & Documentation

Update startup trackers, reporting tools, and operational systems accurately and promptly
Track outstanding approvals, startup dependencies, and aging deliverables
Prepare startup status updates and operational reports for leadership review
Ensure startup documentation is organized, complete, and maintained according to internal processes
Support reporting accuracy and operational visibility across assigned studies

1. Risk Identification & Issue Escalation

Identify startup delays, operational concerns, or workflow gaps impacting startup timelines
Escalate outstanding issues or barriers impacting startup progress appropriately
Support follow-up on mitigation plans and operational action items
Assist with maintaining startup quality and operational readiness standards

1. Process Consistency & Team Support

Follow standardized startup workflows, processes, and communication practices
Support onboarding and training activities for new SSU team members as assigned
Assist with the development and maintenance of startup trackers, workflow tools, and guidance documents
Participate in startup process improvement and operational efficiency initiatives
Promote accountability, organization, and operational consistency across assigned activities

1. Other Duties

Perform additional operational responsibilities as assigned by management

KNOWLEDGE & EXPERIENCE

Education

Associate’s or Bachelor’s degree in Life Sciences, Healthcare Administration, Business Administration, or related field preferred
Equivalent clinical research experience may be considered

Experience

1–3+ years of clinical research, startup coordination, regulatory support, or clinical operations experience preferred
Experience supporting startup timelines, documentation tracking, or operational workflows preferred
Experience working within a clinical research site, CRO, sponsor, or research network environment preferred
Experience coordinating multiple tasks and priorities in a fast-paced operational setting is preferred

Credentials

ACRP or SOCRA certification preferred but not required

Knowledge and Skills

Basic understanding of clinical trial startup workflows and activation processes
Working knowledge of clinical research operations and regulatory documentation preferred
Strong organizational and task management skills
Ability to manage multiple assignments, timelines, and operational follow-up activities simultaneously
Strong attention to detail and follow-through
Excellent verbal and written communication skills
Strong interpersonal and team collaboration skills
Ability to identify and communicate operational concerns appropriately
Experience with Microsoft Office Suite, Google Workspace, and startup tracking systems preferred
Ability to function effectively in a fast-paced, team-oriented operational environment
Ability to maintain professionalism and responsiveness with internal and external stakeholders

Qualifications