Senior Regulatory Specialist - Clinical

Medasource; Philadelphia (Philadelphia County); Hybride; USD 105 000 - 145 000; Plein temps

Résumé du poste

Medasource is seeking a Senior Regulatory Specialist – Clinical to support investigator-initiated trials from a sponsor perspective. The role emphasizes sponsor oversight, site/vendor oversight, regulatory compliance, and trial quality in a hybrid PA setting.

The ideal candidate has 5–7 years of related experience, TMF expertise, and the ability to manage multiple studies with strong documentation and communication skills.

Qualifications

• Bachelor’s degree in a life sciences or related field is required.
• 5–7 years of clinical research, clinical operations, or regulatory experience.
• Experience overseeing trials from the sponsor perspective.
• Knowledge of FDA regulations and ICH-GCP.
• Strong written communication and document management skills.

Responsabilités

• Oversee Phase I–IV clinical trials from the sponsor perspective.
• Provide sponsor and site oversight during startup, execution, and closeout.
• Conduct vendor qualifications and ongoing oversight.
• Ensure study activities comply with SOPs, FDA regulations, and ICH-GCP.
• Review core documents: protocols, ICFs, IBs, study manuals, and IRB docs.
• Maintain the TMF and sponsor records.
• Support pharmacovigilance and safety reviews across studies.
• Prepare and support FDA regulatory submissions (amendments, annual and safety reports).
• Work with auditors to ensure inspection readiness.
• Escalate issues to leadership as needed.
• Independently manage multiple studies across priorities.

Connaissances

Sponsor oversight

Regulatory oversight

Documentation management

Quality oversight

Written communication

Formation

Bachelor's degree

ACRP/SOCRA/RAC certifications

Outils

Veeva Vault

eTMF

CTMS platforms

Description du poste

Position: Senior Regulatory Specialist – Clinical

Location: Pennsylvania | Hybrid, onsite approximately 2 days/month

Contract Length: 6+ Months - potential to extend and/or convert to FTE

Schedule: Monday–Friday, approximately 9:00 AM–5:00 PM

Start Date: ASAP

Position Overview:

Our client is seeking a Senior Regulatory Specialist – Clinical to support investigator-initiated Phase I–IV clinical trials. This position sits within clinical operations and is primarily focused on sponsor oversight, site and vendor oversight, regulatory compliance, and clinical trial quality.

The ideal candidate will have experience overseeing clinical trials from the sponsor perspective and be comfortable independently managing study documentation, TMFs, vendors, quality activities, and regulatory requirements throughout the clinical trial lifecycle.

Key Responsibilities:

• Oversee Phase I–IV clinical trials from the sponsor perspective
• Provide sponsor and site oversight throughout study startup, execution, and closeout
• Conduct vendor qualifications and provide ongoing vendor oversight
• Ensure study activities are conducted in accordance with established SOPs, FDA regulations, and ICH-GCP
• Review and manage core clinical documents, including protocols, informed consent forms (ICFs), investigator brochures (IBs), study manuals, and IRB documentation
• Maintain and oversee the Trial Master File (TMF) and sponsor records
• Provide quality oversight, including document consistency, version control, and inspection readiness
• Support pharmacovigilance activities by reviewing safety information and evaluating potential impacts across studies
• Prepare and support FDA regulatory submissions, including amendments, annual reports, and safety reports
• Work with auditors as needed and ensure assigned studies remain audit and inspection ready
• Prepare documentation for sponsor oversight, DSMB, and Medical Monitor review
• Resolve regulatory and data-related queries and upscale concerns to leadership when appropriate
• Work independently across multiple studies and competing priorities

Qualifications:

• Bachelor’s degree with 5–7 years of relevant clinical research, clinical operations, or regulatory experience, or an equivalent combination of education and experience
• Clinical operations experience overseeing trials from the sponsor perspective
• Experience with sponsor oversight, site oversight, and vendor qualification/oversight
• Strong experience with TMF management and core clinical trial documents
• Knowledge of pharmacovigilance and clinical trial safety activities
• Quality oversight experience, including version control, sponsor records, and audit support
• Experience supporting FDA regulatory submissions
• Thorough knowledge of FDA regulations and ICH-GCP
• Ability to independently manage studies and determine when issues require escalation
• Strong written communication, organization, and attention to detail
• Proficiency with Microsoft Office and Adobe

Preferred Qualifications:

• Clinical trial data or database experience
• Experience with Veeva Vault, eTMF, and/or CTMS platforms
• Experience supporting investigator-initiated clinical trials within an academic medical center
• ACRP, SOCRA, and/or RAC certification

This is a hybrid position requiring onsite presence approximately 2 days per month in Pennsylvania. There is flexibility for candidates who live outside the immediate Philadelphia area and are able to commute onsite as required.

The team is looking for someone who is curious, eager to learn, excited about clinical research, and comfortable applying their previous experience in a collaborative environment.