Jobs in the United States

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Added 1 min ago
OC
Senior Clinical Trials Coordinator
Olympus Corporation of the Americas
Center Valley, PA
- $59,549 to $80,390 USD / year
The Senior Clinical Trial Coordinator (SCTC) is responsible for the coordination and administration of clinical trials under the direction of the Dir. Clinical Projects. The SCTC will…
Added 1 min ago
Senior Specialist, Digital Process & Data Analysis
Merck
Upper Gwynedd, PA
The Senior Specialist, Digital Process & Data Analysis (DPDA) serves as a strategic partner in advancing data-driven decision-making and digital capability adoption across the organization.…
Added 1 min ago
Associate Director, Oncology Translational Research, Hematology
J&J Family of Companies
Spring House, PA
The Heme Translational Research (TR) group is seeking an experienced clinical biomarker lead (Associate Director) to develop and execute key aspects of Johnson & Johnson Innovative…
Added 1 min ago
Sr. Principal Scientist Oncology Translational Research, Prostate
J&J Family of Companies
Spring House, PA
We are seeking a highly motivated Senior Principal Scientist/ Associate Director in the Translational Research organization to lead biomarker and translational science efforts across…
Added 1 min ago
Senior Manager, Actuarial
CVS Shared Services Resources LLC
Remote, United States
The Senior Manager, Actuarial is responsible for pricing and risk management for the Professional Employer Organization (PEO) segment. The Senior Manager will collaborate with internal…
Added 1 min ago
Float Senior Universal Banker
Baycoast Bank
Cranston, RI
POSITION TITLE: FLOAT SENIOR UNIVERSAL BANKER
Added 2 mins ago
Specialty Representative/Senior Specialty Representative - Primary Care - Eugene, OR
Amgen
Eugene, OR · Medford, OR · Bend, OR
SPECIALTY REPRESENTATIVE/SENIOR SPECIALTY REPRESENTATIVE
Added 2 mins ago
Associate Director, Senior Patient Safety Scientist
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
The Associate Director, Senior Patient Safety Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety…
Added 2 mins ago
Associate Consultant, Regulatory Science and Strategy
IQVIA
Wayne, PA
The Associate Consultant plays a key supporting role in the delivery of strategic regulatory engagements. Working alongside senior RSS team members, epidemiologists, and former regulators,…
Added 3 mins ago
Senior Component Level Electronics Test Technician
Acara
Canonsburg, PA
Added 3 mins ago
CB
Associate Director, Clinical Operations Site Engagement Lead
CSL Behring
King of Prussia, PA
- $186,000 to $220,000 USD / year
Working in close collaboration with Clinical Development, Clinical Trial Management, Site Management, Feasibility, Start-up, Medical Affairs, and other functions, the Associate Director,…
Added 3 mins ago
Associate Automation Engineer - 2nd Shift
GlaxoSmithKline LLC
King of Prussia, PA
Added 3 mins ago
Sr Service Manager
Ryder System
Allentown, PA
The Senior Manager Operations II manages the operations and personnel for approximately 601+ equivalent truck units comprised of one or more locations. May have Operations Managers,…
Added 4 mins ago
Associate Director, Omnichannel Therapeutic Area Lead
Otsuka America Pharmaceutical Inc.
Harrisburg, PA
Serve as a strategic thought partner to Brand, Medical, and Commercial leadership, contributing to the development of customer engagement strategy and plans informed by deep customer…
Added 4 mins ago
IG
Senior Business Analyst
Insight Global
Remote, United States
- From $82 USD / hour
- Experience partnering with Marketing teams to implement regulatory and process requirements.
Added 4 mins ago
Senior Learning Design Professional
Humana
Harrisburg, PA
Humana’s Center of Excellence Curriculum Team is seeking a Senior Learning Design Professional who is experience in adult learning to support the Provider Contact Center. As the Senior…
Added 4 mins ago
Associate Director, Clinical Outcome Assessments (COA)
Otsuka America Pharmaceutical Inc.
Harrisburg, PA
The Associate Director, COA develops and executes the COA strategy for one or more assigned clinical programs, applying qualitative and quantitative methods to support endpoint selection,…
Added 4 mins ago
Sr Site Reliability Engineer -Remote US
SitusAMC
Harrisburg, PA
…reliable. Additionally, enhancing automation capabilities, scaling, process improvement, metric collection, security, and visibility into the product environments. Leveraging various DevOps…
Added 4 mins ago
Senior Companion Animal Territory Representative - (Delaware/ Maryland Eastern Shore)
Merck
Harrisburg, PA
…business model, key influencers (Owner/Practice Manager/Key Tech/Associate Vet/Front office staff), customer needs and identifies business…
Added 4 mins ago
Operations Project Manager
Copeland
Harrisburg, PA
Capture lessons learned and transition completed deliverables to process owners with documented controls and sustainment plans
Added 4 mins ago
Senior Director, Global Clinical Development Psychiatry and Neurology
Otsuka America Pharmaceutical Inc.
Harrisburg, PA
Otsuka is seeking a Senior Director, Global Clinical Development remote based or in our Rockville, MD or Princeton, NJ offices, who will be responsible for the design and oversight of…
Added 4 mins ago
Platform Engineer - Remote
SitusAMC
Harrisburg, PA
Minimum of 6+ years of industry and/or relevant experience, typically with 1+ years in a Senior Associate level role or external equivalent
Added 4 mins ago
Specialty/ Senior Specialty Representative - Dermatology - Pittsburgh North, PA
Amgen
Pittsburgh, PA
…meaningful careers through challenging assignments, career development, and valuable opportunities such as this opportunity to craft a long-term career with Amgen. The Specialty/Senior…
Added 4 mins ago
Assistant Director, University Events & Engagement - University Advancement
Carnegie Mellon University
Pittsburgh, PA
Reporting to the Senior Associate Director of University Events and Engagement, this role is responsible for supporting and helping manage reunion programming with the Reunion team,…
Added 4 mins ago
Oracle Fusion Manufacturing Senior Manager - Pharmaceutical
Accenture
Pittsburgh, PA · Philadelphia, PA
As a Senior Manager, you will drive client engagement delivery, mentor consulting teams, support business development activities, and serve as a trusted advisor to executive stakeholders.

PPD Development, LP

FSP Sr CRA I

Remote, United States

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Job details

Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
Posting language: English
Posted: Nov 5, 2026

Original job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Join Us as Senior Clinical Research Associate I – 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. DESCRIPTION As a Senior Clinical Research Associate I in our FSP model, you will be dedicated to one specific client, acting as a representative of the client while exercising strong communication and collaboration skills. You will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will act as a site processes specialist, ensuring 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.

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.
Maintains 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.
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, CTMS).
Performs QC check of reports generated from CTMS system where required.
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.
Ensures 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.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Facilitates effective communication between investigative sites, the client company and the 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 other project work and initiatives for process improvement, as required.

REQUIREMENTS

Education and Experience Requirements:

Bachelor's degree in a life sciences 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 3+ years).
Oncology experience preferred.

Knowledge, Skills and Abilities:

A seasoned, experienced professional, with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
Strong critical thinking and problem-solving skills.
Excellent clinical trials monitoring skills; remote and on-site.
Demonstrated understanding of ICH-GCP guidelines, applicable regulations and SOPs.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
Strong communication and collaboration skills with ability to interact effectively with investigative sites, clients, and internal teams.
Ability to act as a representative of the client while maintaining professional relationships.
Advanced written and oral communication skills.
Strong organizational skills and attention to detail.
Demonstrated use of computer systems including CTMS and other trial management platforms.
Ability to travel >75% as required for site monitoring activities.

Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference. Apply today to help us deliver tomorrow's breakthroughs.

Compensation and Benefits The salary range estimated for this position based in Colorado is $90,000.00–$113,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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More about this job

Skills

Clinical research
Clinical trials
Communication skills
Collaboration
Regulatory compliance
Documentation
Google Cloud
Root cause analysis
Critical thinking
Problem solving
Monitor activities
Inspection
Process improvement
Organizational skills
Attention to detail

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