Sr. Clinical Research Associate Job at iconplc (DALLAS, TX, HOUSTON, TX)

In-house Sr Clinical Research Associate

A clinical-stage biopharmaceutical company in San Diego, California is seeking a...

Location

United States , San Diego

Salary:

60.00 - 75.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor degree preferred
3 years of CRA experience
Site management and CRO/vendor oversight
Proficiency with Microsoft Office and Veeva eTMF required
Phase I–III Experience

Job Responsibility

Support clinical operations across multiple studies while ensuring subject safety and data integrity
Review and maintain the electronic Trial Master File (eTMF) in compliance with SOPs, GCP, and ICH guidelines
Support study start-up and ongoing trial activities, including regulatory documentation and site readiness
Serve as a liaison between internal teams, CROs, vendors, and investigator sites
Review monitoring visit reports (PSV, SIV, IMV, COV)
Remotely track enrollment and treatment status using IxRS and EDC systems
Maintain study tracking tools, meeting minutes, and action items
Participate in investigator meetings, study training, and co-monitoring activities as needed
Perform duties in compliance with FDA regulations, ICH-GCP, and company policies

What we offer

Medical
dental
vision
401(k)
telehealth services
ESOP
commuter benefits

Fulltime

Senior Clinical Research Associate - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

South Korea

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Fluent in English and in the native language(s) of the country they will work in
Extensive knowledge of clinical trial methodologies, ICH/GCP and local country regulations
Global clinical trial experience
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Demonstrated knowledge of clinical research and development processes
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research
Demonstrated knowledge in disease and technical areas pertaining to clinical studies
Demonstrated ability to support sponsor regulatory interactions/inspections

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed
Partner with SCP to perform investigator site development, coaching and training of site personnel
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs)
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes

What we offer

Patient-focused culture
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology - East Coast. ICON plc is a world-...

Location

United States , Atlanta; Texas; Maryland; Missouri; Tennessee; North Carolina; Illinois; Ohio; Florida; Philadelphia, PA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

An undergraduate degree or it’s equivalent in clinical, science, or health related field from an accredited institution
a licensed health care professional (i.e. registered nurse) or equivalent work experience required
5+ years clinical monitoring experience required (Sr CRA)
Knowledge of ICH and local regulatory authority regulations regarding drug
Read, write and speak fluent English
Oncology monitoring experience required
Experience doing feasibility/site selection/site start up required
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines
Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites
Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations
Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
Provides regular site status information to team members, trial management, and updates trial management tools
Completes monitoring activity documents as required by sponsor's SOPs
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
Escalates site and trial related issues per Sponsor's SOPs until identified issues are resolved or closed
Performs essential document site file reconciliation
Performs source document verification and query resolution

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Equity Sr. Research Associate - Biotech

Under general supervision of a Senior Equity Analyst, analyze and interpret clin...

Location

United States , New York

Salary:

80000.00 - 150000.00 USD / Year

Raymond James

Expiration Date

Until further notice

Requirements

Equivalent work experience or Ph.D/Md/PharmD required
Biochemistry, Neuroscience, or other life science focus strongly preferred
Business/Finance grads with some life science career experience also considered
Data analytics/coding skills preferred
Obtain the Series SIE, 86/87, and 63 licenses within one year from start date
General Experience - 6 to 10 years
Doctor of Medicine (MD) or MBBS (Required)
Doctor of Philosophy (PhD) or similar Doctorate Degree (Required)
Master's: Business Administration (Required)
Securities Industry Essentials Exam (SIE) - Financial Industry Regulatory Authority (FINRA)

Job Responsibility

Develops expertise on the biotechnology industry and individual biotech companies to assess the impact of clinical data readouts and other impactful news
Prepare and coordinate the completion of various data and analytics reports, including financial models for revenue and income forecasts, cash flow analysis, balance sheet, and quarterly projections
Assembles and analyzes clinical, scientific and other data to help inform investment ideas/ views on market outlook
Explores and develops a basic understanding of external developments or emerging issues and contribute to the evaluation of their potential impact on an investment recommendation
Build effective working relationships within the internal client organization, delivering high-quality professional services with guidance from senior colleagues
Develop own capabilities by participating in assessment and development activities as well as formal and informal training and coaching
gain or maintain external professional accreditation, where relevant, to improve performance and fulfill personal potential
Maintain an understanding of relevant technology, external regulation, and industry best practices through ongoing education, conferences, and reading specialist media

Fulltime

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

New

Study Delivery Sr Associate

The Study Delivery Senior Associate provides essential global study management s...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree OR Bachelor's degree and 2 years of clinical execution experience OR Associate's degree and 6 years of clinical execution experience OR High school diploma / GED and 8 years of clinical execution experience
3 years' work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience working on global clinical trials
Strong collaborative and effective communication skills within a team environment
Understands importance of accuracy in documentation, data tracking, and compliance checks
Identifies discrepancies and escalates appropriately
Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
Ability to maintain accurate and timely data entry

Job Responsibility

Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility
Coordinate logistics for investigator meetings, trial events, and site communications
Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards
Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks
Lead delivery of assigned risk and quality management activities
Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance
Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved
Manage Study Training system activities and oversight
Build and maintain effective relationships with internal study team members, vendors and investigator sites
Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned

Data Management Sr Associate

At Amgen, if you feel like you're part of something bigger, it's because you are...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree
Bachelor's degree and 2 years of clinical execution experience
Associate's degree and 6 years of clinical execution experience
High school diploma / GED and 8 years of clinical execution experience

Job Responsibility

Execute study data management tasks including database build testing, data cleaning, query management, reconciliation, and lock preparation with limited oversight
Support core Data Management roles, such as Data Delivery Leads, Database Designers, and Data Acquisition Leads by owning time-sensitive deliverables with high-quality execution
Actively contribute to setup and maintenance of EDC/non CRF data structures including local labs, coding dictionaries, along with non-CRF data integrations
Track progress against data management timelines, study timelines and deliverables, identify risks or delays, and escalate issues with clear documentation and any mitigations
Coordinate with local internal teams, global team members as well as external partners (including FSPs) when required to ensure aligned and efficient delivery of all study activities
Identify opportunities to improve repeatable processes and contribute to best practices and knowledge sharing across the team

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Sr Associate Medical Science Liaison Hematology

Location

Italy , Milan

Salary:

46697.30 - 63178.70 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctoral Degree or Master’s degree in Sciences
One/Two years of industry experience in Scientific/Medical Affairs at a biotech or pharmaceutical company
TA expertise
Based in Lazio/Campania

Job Responsibility

Be field-based medical expert in the Medical Science Liaison (MSL) group within Medical organization
Be an integral position in communicating accurate, clear, and valued information regarding our science and products to multiple levels within the medical community and are responsible for gathering field insights for internal stakeholders
Support medical strategic roles in developing local territory R&D tactics
Engage with healthcare stakeholders to educate and communicate clinical and scientific data to advance the scientific platform as aligned with Amgen’s corporate goals and objectives
Educate and communicate clinical value, outcomes, and economic data to payers, providers, key stakeholders, advocacy, and access enablers
Respond to unsolicited inquiries consistent with the MSL compliance standards
Provide and/or present field observations and insights to internal stakeholders
Execute scientific engagement plan according to annual MSL goals and metrics
Develop and implement local OL plans in line with scientific engagement plan
Support speaker training as requested and ensure the speakers are updated on new data

What we offer

Full support and resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Fulltime

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Sr. Clinical Research Associate

Job Description

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