Job Title: Study Start-Up Specialist

Reports To: Regulatory Manager

Department: Compliance (Will eventually be in ClinOps)

FLSA Status: 

Business Unit: IRO Services / Site Network- Remote

Summary: The Study Start-Up Specialist is responsible for coordinating and supporting the regulatory and administrative activities required to efficiently initiate clinical research studies at the site. This position works closely with the Regulatory, Clinical Operations, Investigators, Sponsors, CROs, IRBs, and other stakeholders to ensure study start-up activities are completed accurately, efficiently, and in accordance with applicable regulations, GCP, ICH guidelines, sponsor requirements, and company SOPs.

The Study Start-Up Specialist serves as a key point of coordination during study activation and is responsible for tracking start-up requirements, preparing and submitting essential documentation, facilitating communication with internal and external stakeholders, and identifying outstanding items that may impact study activation timelines.

In addition to study start-up responsibilities, this position may provide regulatory department overflow support based on departmental workload and business needs. Regulatory support may include document maintenance, submissions, regulatory binder management, investigator and staff documentation, audit and monitoring preparation, and other administrative regulatory activities.

Duties and Responsibilities:

Study Start-Up

• Coordinate assigned clinical research studies from study award through site activation, including start-up timelines, trackers, and action items.
• Review protocols, informed consent documents, and study-specific requirements to identify regulatory and operational start-up needs.
• Coordinate collection, preparation, review, and submission of essential documents to sponsors, CROs, IRBs, and other applicable entities.
• Prepare and coordinate initial IRB submissions and required regulatory documentation, including Form FDA 1572s, financial disclosures, informed consent documents, investigator brochures, recruitment materials, and applicable licenses and certifications.
• Track submissions, approvals, stipulations, and outstanding items through study activation; coordinate responses to sponsor, CRO, and IRB requests.
• Coordinate collection and review of investigator and research staff qualifications, including CVs, licenses, certifications, and training documentation.
• Support site qualification, feasibility, site initiation visits (SIVs), investigator meetings, and other study activation activities.
• Ensure required start-up documentation is complete, current, and appropriately filed in the Investigator Site File (ISF) or applicable electronic system.
• Identify and escalate missing documentation, compliance concerns, and other issues that may impact study activation timelines.
• Maintain accurate start-up records and communicate study status and outstanding items to relevant stakeholders.
• Maintain confidentiality of subject, investigator, sponsor, and study-related information.

Regulatory Department Overflow Support

Provide support to the Regulatory Department as needed to maintain timely completion of regulatory activities across active clinical trials, including:

• Assist with preparation, submission, and tracking of amendments, continuing reviews, renewals, study closures, final reports, and other regulatory submissions.
• Maintain regulatory binders and electronic regulatory systems, including document filing, reconciliation, and quality control.
• Maintain regulatory logs and trackers and assist with ongoing investigator and staff documentation.
• Prepare regulatory correspondence and documentation, including cover letters, notes-to-file, memos, and other study-related records.
• Assist with monitoring visits, audits, inspections, and study archival activities.
• Identify and resolve missing, expired, or inconsistent regulatory documentation in coordination with appropriate personnel.
• Provide additional regulatory and administrative support based on departmental needs.

Qualifications

Required

• Bachelor’s degree in a scientific, health-related, or relevant field, or equivalent combination of education, training, and experience.
• 2–4 years of experience in clinical research, regulatory affairs, study start-up, or a related field.
• Working knowledge of FDA regulations, 21 CFR, ICH/GCP, HIPAA, and IRB requirements.
• Experience with clinical trial and/or regulatory documentation.
• Proficiency with Microsoft Office, particularly Word and Excel.
• Familiarity with electronic regulatory systems, CTMS, eTMF, or other clinical research platforms.
• Strong organizational, written, and verbal communication skills with exceptional attention to detail.
• Ability to independently manage multiple studies, priorities, and time-sensitive deadlines.
• Ability to collaborate effectively with investigators, research staff, sponsors, CROs, IRBs, and internal departments.
• Completion of required CITI, GCP, and company-specific training.

Strongly Preferred

• Experience with clinical trial study start-up and site activation.
• Experience with IRB submissions and correspondence.
• Experience working directly with sponsors and CROs.
• Experience with Clinical Research IO (CRIO) or similar electronic regulatory platforms.
• Experience supporting pharmaceutical and/or medical device research.
• Knowledge of FDA Form 1572, financial disclosure requirements, investigator qualifications, and essential document requirements.
• Familiarity with medical terminology.

FLSA Classification:

Work Environment and Physical demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.