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Added 2 mins ago
Area Superintendent
SUNSHINE ENTERPRISE USA LLC
Sanford, FL
Monitor regional projects and report issues, risks, and scope changes to the General Superintendent and Project Manager
Added 2 mins ago
Construction Project Manager
SUNSHINE ENTERPRISE USA LLC
Jacksonville, FL
Lead all phases of project planning, execution and closeout for assigned construction projects.
Added 2 mins ago
Project Superintendent I
SUNSHINE ENTERPRISE USA LLC
Charlotte, NC
Added 4 mins ago
Traveling Project Manager, Mechanical Construction (Nationwide)
GPAC
Manchester, NH
A well-established mechanical contractor is hiring a Traveling Project Manager to lead mechanical construction projects at jobsites across the country. You'll be onsite for the life of each…
Added 4 mins ago
Project Manager - Healthcare Construction
GPAC
Dallas, TX
A respected general contractor in Dallas is hiring a Project Manager to lead hospital, medical office and outpatient projects from preconstruction through closeout.
Added 7 mins ago
SR Specialist, Training and Development, Customer Operations
Boehringer Ingelheim
Johns Creek, GA
Added 7 mins ago
Business Development Manager, Digital Power
Siemens
Peachtree Corners, GA
Position Title: Business Development Manager - Certified Provider Program (Digital Power)
Added 7 mins ago
Product Marketing Manager
Siemens
Peachtree Corners, GA
Added 7 mins ago
Office Manager
The Davey Tree Expert Company
Villa Rica, GA
The Office Manager is responsible for overseeing the daily administrative, operational, and facility functions of our engineering and utility design office in Villa Rica, Georgia. Working…
Added 7 mins ago
Safety & Health Spec/Advisor - Combined Cycle - GA Job Details | Black & Veatch Family of Companies
Black & Veatch
Cartersville, GA
Added 7 mins ago
Safety & Health Administrator - Combined Cycle - GA Job Details | Black & Veatch Family of Companies
Black & Veatch
Newnan, GA
Added 7 mins ago
A
Construction Quality Control Manager (QCM) - Albany, GA
Aerotek
Warner Robins, GA
- $50 to $60 USD / hour
We are seeking an experienced Construction Quality Control Manager (QCM) to support a large federal military construction project in Albany, GA. The project is approximately 20% complete an
Added 7 mins ago
Account Manager
Taylor
Duluth, GA
Added 8 mins ago
Manager, Implementation Small Business Services
ADP
Alpharetta, GA
ADP Small Business Services is hiring an Implementation Team Manager.
Added 8 mins ago
Program Manager
ManpowerGroup
Alpharetta, GA
Our client, a leader in financial technology and payments operations, is seeking a Program Manager to join their team. As a Program Manager, you will be part of the Conversion Delivery…
Added 8 mins ago
G
Project Manager - Diverse Commercial Construction
GPAC
Memphis, TN
- $105,000 to $135,000 USD / year
…contractor with in-house MEP capabilities. The company is adding a Project Manager - Diverse Commercial Construction to its team in Memphis, TN. This is an urgent, high-priority…
Added 8 mins ago
Director, Functional Platform Leader
The Coca-Cola Company
Atlanta, GA
Added 8 mins ago
Supply Chain Lead Finance Specialist
GE Vernova
Atlanta, GA
Added 8 mins ago
Project Coordinator II-Sr
Southern Company
Atlanta, GA
Project Coordinator – DER Software, Analytics, and Product Enablement
Added 8 mins ago
Talent Management Manager - Performance Management
Graphic Packaging International, LLC
Atlanta, GA
Added 8 mins ago
Deals Accelerated Solutions IT Manager
PwC
Atlanta, GA
As a Deals Accelerated Solutions IT Manager you will lead client service work focused on IT cost and value management within our Advisory practice, helping shape technology approaches that…
Added 8 mins ago
Field Marketing Project Manager
CGI Technologies and Solutions, Inc.
Atlanta, GA
Our client, a major brand here in Atlanta, is seeking a Field Marketing Project Manager to join their team. This person will be responsible for providing day to day coordination and…
Added 8 mins ago
Operations Change Manager
U.S. Bank
Atlanta, GA
Added 8 mins ago
LMS Azure AWS Saleforce Support Canvas Manager
COOLSOFT
Atlanta, GA
Job Description Manager: LMS, Workforce Development, Cloud Platforms, Azure AWS Saleforce Suppor
Added 8 mins ago
Manager SAP Project NA
Smurfit Westrock
Atlanta, GA
The Manager SAP Project NA oversees the estimation, planning, execution, and delivery of projects for the Global SAP CoE ensuring that they are completed on time, within budget, and to the…

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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