Job Description:
Job Summary
The Senior Clinical Studies Associate supports the planning, execution and oversight of clinical studies throughout the study lifecycle. Working under the guidance of Clinical Study Manager and cross-functional study teams, the SCSA contributes to study operations, documentation, regulatory compliance, and process improvement initiatives. This role requires strong organizational skills, attention to detail, ability to coordinate effectively with stakeholders to ensure successful study execution and adherence to quality standards.
Essential Duties and Responsibilities
Clinical Study Execution & Coordination
- Support the planning, execution, and day-to-day management of clinical studies and projects.
- Develop study timelines, milestones, and project tracking tools.
- Coordinate study meetings, prepare agenda, document meeting minutes, and track action items to completion
- Facilitate communication among cross-=functional teams, investigators, CROs and internal and external stakeholders
- Support study startup, maintenance and closeout activities.
- Identify and escalate routine study issues, risks, or delays as appropriate.
Clinical Documentation & Compliance
- Draft, update, and maintain clinical study documentation in accordance with regulatory requirements, GCP guidelines and company procedures.
- Support the development, review, and completeness of study documents, including protocols, study plans, and essential documents for regulatory submissions.
- Conduct routine clinical data reviews and support data quality activities.
- Ensure timely filing, quality review, and completeness of Trial Master File (TMF) documentation.
- Assist with development and validation of case report form (CRF), and data validation activities, including associated training and documentation.
- Maintain study records and controlled documentation in accordance with quality system requirements and document control procedures.
- Support audit and inspection readiness activities by ensuring documentation is complete, accurate, and current.
Regulatory & IRB Support
- Prepare, coordinate, and track IRB submissions and related activities, including initial submissions, continuing reviews, and amendments.
- Maintain IRB tracking tools, monitor submission timelines, and manage associated documentation and invoices.
- Support regulatory documentation activities under the guidance of senior team members.
Process Improvement & Operational Support
- Support updates to SOPs, work instructions, templates, and operational tools as needed.
- Contribute to continuous improvement initiatives that enhance study execution, compliance, and operational efficiency.
PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.
Minimum Qualifications, Education and Experience
- Bachelor’s degree in life sciences or related field (required); advanced degree preferred.
- Minimum 2 years of related clinical research experience; or an advanced degree without experience; or equivalent work experience.
- Working knowledge of Good Clinical Practice (GCP) and applicable regulatory guidelines.
- Attention to detail and ability to manage multiple tasks concurrently.
- Strong organizational and communication/collaboration skills.
- Proficiency with clinical trial management systems and related tools.
Quality Standards
- Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, visitors, and vendors.
- Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
- Follows all local, regional and country laws concerning employment.
- Follows all DeepHealth policies and procedures.
- Follows data privacy, compliance, safety and confidentiality standards at all times.
- Practices universal safety precautions.
- Promotes good public relations on the phone and in person.
- Adapts and is willing to learn new tasks, methods, and systems.
- Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with DeepHealth guidelines.
- Completes job responsibilities in a quality and timely manner.
Travel
This position requires domestic / international travel up to 10%.
Working Environment
Remote / Office / Hybrid
Physical Demands
This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally.
I have read and understand the responsibilities and requirements of the position.
Salary dependant upon experience $71,000 to $96,000
Pay Range:
USD $71,000.00 - USD $96,000.00 /Yr.