375 matching jobs for “Clinical Study Specialist”

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Thermo Fisher Scientific

FSP Clinical Research Associate II

Remote, Romania

Join Us as a FSP Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully …

Added Oct 16, 2026

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Thermo Fisher Scientific

International Freight Specialist

Taipei, Taiwan

… Join our team at Thermo Fisher Scientific where you'll contribute to managing logistics operations for clinical trials, pharmaceutical products, and scientific equipment. As a Logistics Specialist I, you'll coordinate …

Added Oct 16, 2026

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Thermo Fisher Scientific

Senior Clinical Research Associate I

Auckland, New Zealand +1 location

… cures for cancer. Location/Division Specific Information Performs and coordinates different aspects of the clinical monitoring and site management process. This home-based position requires candidates to currently be …

Added Oct 25, 2026

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Thermo Fisher Scientific

Contract Specialist I

Samorin, Slovakia

… making sure our food is safe or helping find cures for cancer. DESCRIPTION: Join our team as a Contracts Specialist I at Thermo Fisher Scientific, where you'll contribute to our mission to enable customers to make the world …

Added Oct 16, 2026

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Thermo Fisher Scientific

Associate Contract Specialist

Remote, United Kingdom

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Sr Clinical Research Associate

Remote, Mexico +1 location 3 postings

… taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research …

Added Oct 20, 2026

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Thermo Fisher Scientific

FSP Sr Clinical Research Associate

Remote, Mexico +1 location 4 postings

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Clinical Research Associate II

Remote, Mexico

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Sr Clinical Research Associate

Remote, North Carolina, USA

Sr CRA (Level I) Purpose: Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory …

Added Oct 25, 2026

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Thermo Fisher Scientific

Operational Bidding Specialist

Remote, Mexico

… making sure our food is safe or helping find cures for cancer. DESCRIPTION: The Operational Bidding Specialist plays a critical role in the preparation and delivery of competitive, high-quality operational bids and …

Added Oct 16, 2026

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Thermo Fisher Scientific

Clinical Research Associate I (FSP)

Sydney, Australia +2 locations

… Role: As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level I), you'll conduct remote …

Added Oct 16, 2026

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Gilead Sciences

Sr Director, Clinical Development (MD)

Foster City, California, United States +3 locations

Full time
Regular

Pay posted by employer$302,005–$390,830

The Senior Medical Director provides clinical oversight to one or more clinical trials. Additionally, the Senior Director guides the project teams to …

Added Oct 15, 2026

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IQVIA Holdings

Clinical Trial Assistant, Site Management - Romania

Bucharest, Romania

· Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates …

Added Oct 15, 2026

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IQVIA Holdings

Senior Clinical Research Associate - Sponsor Dedicated

Amsterdam, The Netherlands

Why Join Clinical Functional Service Partnerships (CFSP)? At IQVIA, our Clinical Functional Service Partnership (CFSP) model …

Added Oct 15, 2026

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Abbott Laboratories

Sr Therapy Specialist

Korea - Seoul

… solutions for the treatment of structural heart disease. PRIMARY FUNCTION / OBJECTIVE: The Therapy Specialist (TS) has the responsibility (within a defined region of S. Korea) to meet the sales target and develop the …

Added Oct 23, 2026

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Thermo Fisher Scientific

Participation Relations & Resolution Specialist

Austin, Texas, United States

Participation Relations & Resolution Specialist Are You... A critical thinker who asks questions, gathers facts, and considers multiple perspectives before …

Added Oct 16, 2026

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IQVIA Holdings

Database Management Specialist

Bengaluru, India

- Develop, validate, and maintain SAS programs for clinical study deliverables. Generate and review Data Validation Listings (DVLs) to ensure data accuracy, …

Added Oct 15, 2026

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Regeneron Pharmaceuticals

Medical Director, Clinical Development, Cardiology/Nephrology

TARRYTOWN

Full time
Regular

Pay posted by employer$284,900–$385,700

… diseases. We are seeking a Medical Director to join our Cardiovascular/Renal/Metabolism team supporting our Clinical Development Unit. In this role, you will serve as Medical Lead for clinical trials and are responsible for …

Added Oct 21, 2026

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IQVIA Holdings

Data Entry Specialist

San Antonio, Texas, United States

Pay posted by employer$25,900–$64,800

… for performing all data entry functions as they relate to the completion of case report forms, by entering study data collected by the research team into the Electronic Data Capture (EDC) system. Data entry personnel …

Added Oct 16, 2026

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Thermo Fisher Scientific

Principal Country Approval Specialist

Remote, Poland

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Clinical Research Associate II

Remote, Romania

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About this opportunity

Original employer description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a FSP Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors. Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

What You’ll Do:
• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary.

• Identifies potential Investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.

Education and Experience Requirements:
• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years as a clinical research monitor).
• Valid driver's license.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexibile and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

Working Conditions and Environment:
• Work is performed in an office and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions

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