Principal In-house CRA – LATAM
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Principal In-house CRA providing support for clinical research across Mexico, Brazil, Argentina, Colombia, Chile, and Peru. Managing trial activities and site interactions to ensure compliance with regulations.
Responsibilities:
- We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru.
- The Principal In-house CRA provides overall support to study sites and clinical project teams engaged in clinical research studies.
- Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements.
- Acting as point of contact for study sites.
- Has extensive site management experience which included experience and knowledge across different type of projects.
- Responsible for providing senior oversight and act as subject matter expert in site management activities.
- Acting as resource for Clinical Monitoring management team support and mentoring and developing others in the team.
- Performs and manages investigator recruitment activities and assists with development of tools such as phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites in partnership with study team.
- Schedules internal and external meetings as required.
- Prepares Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required.
- Performs ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site level data in the trial master file (TMF).
- Assist with sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
- Ensures timely and complete data entry by site in EDC or any other system that requires data entry.
- Sends email blasts/newsletter, updates, and updated study core documents to study site personnel.
Requirements:
- Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
- 6 years of clinical trial or related 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
- In-depth knowledge of the drug development process
- Experienced with utilizing CTMS, TMF, and EDC systems
- Ability to travel as needed.
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Similar Jobs
Virtual Family Nurse Practitioner – CA License
Virtual Nurse Practitioner providing tele-health services for One Medical. Treating patients and collaborating with teams for quality care delivery.
Senior Economic Development Specialist
Senior Economic Development Specialist leading economic development projects for the Bureau of Indian Affairs. Supporting American Indian Tribes and Alaska Native communities through strategic resource development.
Math and Science Tutor
Virtual Math & Science Tutor providing individualized instruction to students across the US. Adapting lesson plans and engaging students through remote platforms in their learning journey.
Appeals and Grievances Coordinator
Primary contact for members, providers, and clients in the appeals and grievances process at Avesis. Timely resolution of dental and vision A&G cases within a regulated managed care environment.
Field Execution Representative
Field Execution Representative responsible for marketing Celsius products and managing retail accounts. Collaborating with managers to implement merchandising initiatives and ensure effective product display.
Senior In-house CRA – LATAM
Senior In-house CRA providing clinical research support for expanding operations in Mexico and LATAM region. Focused on building foundation through study site support and adherence to regulatory requirements.
Account Specialist
Account Specialist managing orders and providing customer support in a remote role for VF Corporation. Collaborating with sales and customers to ensure efficient order processing and delivery.
Senior Contract Negotiator
Senior Contract Negotiator managing the full contract lifecycle for Workday's innovative legal team. Collaborating across departments to ensure compliance and efficiency in contract management.
Beverage Specialist
Beverage Specialist driving brand opportunities in the foodservice beverage portfolio through innovative solutions and customer engagement. Collaborates with CORE Foodservice sales teams to enhance beverage expertise.
Grocery Merchandiser
Grocery Merchandiser assisting with merchandising in grocery stores, pharmacies, or convenience stores. Opportunities for flexible hours and growth within the retail sector.
Revenue Cycle Specialist II
Submits and resolves medical claims while adhering to compliance and departmental policies in a remote setting.
Avionics Technician II
Avionics Technician installing and maintaining avionics and special mission systems for firefighting aircraft. Seeking experienced professionals for a crucial role in aerial firefighting technology.
Program Success Lead
Program Success Lead at Springboard managing the delivery of educational programs. Focused on strategic influence and team management for growth in allied health and AI sectors.
Project Delivery Lead
Project Delivery Lead at Station A, delivering clean energy platform projects through collaboration with teams. Requires 5+ years in clean energy industry and project management expertise.
Solution Specialist
Solution Specialist responsible for initial servicing of client accounts through various communication tools. Collaborate across departments to enhance client experience and resolve inquiries at WEX.
Field Services Specialist – Northeast
Field Services Specialist implementing client adoption programs at Medline, requiring travel across the Northeast U.S. and managing onboarding for new clients.
Speech Language Pathologist – Remote
Speech-Language Pathologist providing remote therapy services to K-12 students. Helping develop communication skills and overcome disorders through a tech-driven platform.
Claims Team Lead – Trucking
Claims Team Lead at Reserv overseeing commercial transportation claims adjustments. Leading a team and leveraging technology for efficient claims handling.
Outbound Call Specialist
Outbound Concierge Specialist engaging with consumers to connect them with service providers. Focused on driving positive experiences through timely outreach and lead qualification.
Orthopedic Surgeon
Orthopedic Surgeon providing expert medical consultation and testimony services for legal cases. Analyzing complex orthopedic cases in collaboration with attorneys and offering expert opinions.