Clinical Research Associate Job at Randstad (Strombeek-Bever)

Clinical Research Associate

The Clinical Research Associate (Monitor) is responsible for supporting clinical...

Location

Salary:

Not provided

HonorVet Technologies

Expiration Date

Until further notice

Requirements

B.S. or B.A. and/or an equivalent combination of education or experience
Minimum of 3 years of experience directly related to the execution of clinical research studies
Available to travel (up to 60%) on short notice and independently manage travel schedules
Must have analytical skills, be detail oriented and have good interpersonal skills
Knowledge of agency guidelines and requirements
Effective written and verbal communication skills
Ability to communicate at all levels of an organization
PC skills
word processing, spreadsheet, database, Internet search and utilization
Flexible and able to work in a fast-paced environment

Job Responsibility

Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits and site initiation visits to ensure applicability of sites for planned study according to application regulatory requirements
Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements
Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent and support Institutional Review Board (IRB) submissions
Train site staff on protocol requirements, source documentation, and case report form completion
Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted
Conduct clinical study site close-out visits and ensure site files are complete, accurate and up to date
File site related documents real-time to ensure Trial Master Files are complete and accurate at all times
Provide study specific information and support report validation activities as requested for clinical study reports
Participates in team meetings and document meeting minutes and tracks action items
Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines

Clinical Research Associate II/Sr. Clinical Research Associate - Oncology

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

Location

United States

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 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner 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
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
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) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed

What we offer

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

Senior Clinical Research Associate

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Proficient in written and spoken English language required
Fluency in local language(s) required
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process

Job Responsibility

Contributes to the selection of potential investigators
In some countries, as required, accountable for study start-up and regulatory maintenance
Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings, as applicable
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Shares information on patient recruitment and study site progress
Drives performance at the sites
Proactively identifies and ensures timely resolution to study-related issues

What we offer

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

Fulltime