Precision Medicine Group
InhouseCRA
“In-house CRA at Precision Medicine Group. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. 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”
What You'll Achieve.
ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulations; ensure milestones and activities are accurately tracked; ensure that the study reporting is current, accurate and complete; allow the timely processing of Investigator Payments
Industry & Context.
independent judgment; critical thinking; resolutions provided by sites to queries
Ability to travel as needed
What They're Looking For.
Must Have
Advanced knowledge of the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint), Customer service demonstrate flexibility and teamwork, Ability to focus on detail for extended periods of time, high attention to accuracy, Ability to communicate both verbally and in writing in English, Having transferrable skills from a related health care field, Ability to travel as needed
Nice to Have
Good organizational skills, Ability to work efficiently in a remote work environment
What You'll Do.
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
Acts as point of contact for study sites
Executes all core responsibilities consistently across several studies
Assists with the investigator recruitment activities utilizing phone scripts
study site materials and other tools for use in evaluating investigative sites
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
Assists in ongoing essential document collection and review
and close-out activities
Assists in 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
Utilizes the Clinical Trial Management System (CTMS) to ensure milestones and activities are accurately tracked
Acts as site contact/liaison for study and site management issues
Escalates issues and risks as needed
Ensures timely and complete data entry by site in EDC or any other system that requires data entry
Sends email blasts/newsletter
and updated study core documents to study site personnel
Assists in providing logistics support in samples management and tracking
Supports investigators and investigative staff in fulfilling obligations regarding local submissions
Assists in data review inclusive of site level data review
resolutions provided by sites to queries
Facilitates database closure and freezing procedures as per study plans
Assist with study tracking via the CTMS
Study specific trackers or Sponsor designated system
Documents site and Sponsor contact and study interactions in a timely and professional manner
Assist in remote review of the electronical 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 under supervision
Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments
May attend site visits as needed
supporting the CRA to ensure sponsor and investigator obligations related to the study documentation are being met and are compliant with applicable regulatory requirements and guidelines
Performs other duties as assigned by management
Performs all tasks in accordance with applicable guidelines
company and sponsor SOPs
study-specific processes
local regulatory requirements
How You'll Work.
Team & Collaboration
Acts as point of contact for study sites; The In-house CRA is a solid team member; Individual works independently as study team member with minimum support in complex activities; Schedules internal and external meetings as required; Acts as site contact/liaison for study and site management issues; Escalates issues and risks as needed; Consults with project team members regarding study site issues; May attend site visits as needed, supporting the CRA
Communication Scope
Ability to communicate both verbally and in writing in English; Good written and verbal communication skills; presentation skills
Process & Methodology
process management, cross-functional coordination, resource planning
Applying for this In-house CRA role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Precision Medicine Group?
Real rants from real employees. Read before you apply.