In-House CRA II
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
In-house CRA II providing overall support to clinical research teams and study sites in LATAM region. Focus on adhering to protocols and assisting in administrative tasks related to clinical studies.
Responsibilities:
- Provide overall support to study sites and clinical project teams engaged in clinical research studies
- Adhere to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements
- Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools
- May assist in identifying study sites by performing site feasibility and recruitment tasks
- Schedules internal and external meetings as required
- Prepares Investigator Site Files including distribution to study sites
- Performs ongoing essential document collection and review
- Organizing and maintaining site level data in the trial master file (TMF)
- Perform set ups and maintain site-related data in applicable clinical systems
- Acts as site contact/liaison for study and site management issues
- Ensures timely and complete data entry by site in EDC
- Sends email blasts/newsletters and updates to study site personnel
- Assists in providing logistics support in samples management and tracking
- Supports investigators in fulfilling obligations regarding local submissions
- Assists in data review inclusive of site level data review
- Assist with study tracking via the CTMS
- Documents site and Sponsor contact and study interactions in a timely manner
- Assist in remote review of the electronic Investigator Site File
- Assists with Investigational Product accountability
- Consults with project team members regarding study site issues
- Provides quality review of the amended site level informed consent template
- Follows up with sites for trial invoices
Requirements:
- Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
- Minimum of 2 years of relevant experience
- High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
- Customer service demeanor; demonstrate flexibility and teamwork
- Ability to focus on detail for extended periods of time, high attention to accuracy
- Fluency in English communication, verbally and in writing
- Working knowledge of the drug development process
- Ability to travel as needed
Benefits:
- (No benefits listed)
Similar Jobs
Global IT Solution Lead – EBS
Global IT Solution Lead overseeing technical architecture implementation at Mosaic. Leading teams and managing digital transformation with a global reach.
Material Handler – Fly-in/Fly-out – Day Shift
Material Handler handling warehouse operations including loading, picking, and packing during a 7 on 7 off rotation for Ryder's commercial fleet management.
Credit Review Officer – Payments, Counterparty
Credit Review Officer at KeyCorp responsible for assessing credit quality through loan reviews. Leading a team and ensuring compliance with internal policies and regulations.
Part-time Nurse Practitioner
Nurse Practitioner delivering patient care in a digital health startup. Join a growing team focused on innovative healthcare solutions.
Engagement Reporting Specialist
Engagement Specialist managing Thrivent Member Network engagement activities and communications. Focusing on event execution, data analytics, and serving as Secretary to TMN Board.
Permit Coordinator
Permit Coordinator supporting permitting operations for telecom infrastructure projects across the U.S. Ideal for early-career professionals eager to build experience in utility permitting and coordination.
Language Specialist, Simplified Chinese
Simplified Chinese Language Specialist coordinating clinical translations and ensuring linguistic quality assurance at Thermo Fisher Scientific.
Lead On Site Services Specialist
Install and maintain AIS & GIS high voltage systems for GE Vernova. Ensure health, safety, and quality standards during projects with a focus on customer coordination and service excellence.
Lead On Site Services Specialist
Installation and maintenance service work on Power Transformers and AIS/GIS systems. Ensuring project specifications and customer coordination in a high-voltage environment.
Global Health & Science Specialist – Biosimilars
Global Hospital & Biosimilars Sales Representative with Pfizer improving patient care by launching new products and driving performance. Responsible for building relationships with healthcare customers and executing business plans.
Senior Payment Specialist – Sponsor-dedicated
Senior Payment Specialist managing payments for clinical trials at Syneos Health. Ensuring compliance with agreements and collaborating with internal teams for process improvements.
In-House CRA II – Mexico
In-house CRA II providing overall support to clinical study sites engaged in research studies. Seeking experienced professional to help build a new regional function in LATAM.
Senior Application Specialist – Okta, IAM
Senior Application Specialist leading Identity and Access Management initiatives in global corporate environments. Defining strategies and implementing Okta solutions with a focus on security and automation.
Repair & Maintenance Specialist
Repair & Maintenance Specialist overseeing maintenance and repair of facilities for Five Below. Managing contractors and ensuring service quality across locations with a focus on operational efficiency.
Broadcast Crew Member
Broadcast Crew Member handling production support roles for sports and campus productions. Setting up broadcasts, ensuring safety, and working flexible hours including nights and weekends.
Campus Ambassador
Campus Ambassador at East Carolina University supporting brand visibility and promotions in local accounts. Engaging with the community through events and education sessions.
Campus Ambassador
Campus Ambassador promoting brands for Boston Beer Corporation at Coastal Carolina University. Engaging in promotional activities in local bars, restaurants, grocery and liquor stores around campus.
Campus Ambassador
Campus Ambassador promoting visibility of products at Auburn University through independent and team efforts. Engaging in campus activities and driving brand awareness at local accounts.
Campus Ambassador
Campus Ambassador promoting products in local accounts around the University of Central Florida. Engaging with students and improving brand visibility in the area through events and promotions.
Campus Ambassador
Campus Ambassador promoting brands at Northern Arizona University events. Working independently and with sales team to enhance product visibility in local accounts.