Job Description
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing, and archiving clinical documents. The Clinical Trial Coordinator-Monitoring (CTC-M) supports clinical supply and non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with Clinical Operations Manager (COM), Clinical Research Manager (CRM) and Clinical Research Associate (CRA). And the person collaborates with finance/budgeting representatives to manage Clinical Trial Research Agreement (CTRAs) and payments.
Responsibilities include, but are not limited to:
Trial and site administration:
•Provide expert assistance with data tracking and reporting tasks to various teams within the Site Management & Monitoring organization
•Ensure collation and distribution of study tools and documents
•Update clinical trial databases (CTMS) and trackers
•Clinical supply & non-clinical supply management, in collaboration with other country roles
•Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
Document management:
•Prepare documents and correspondence
•Collate, distribute/ship, and archive clinical documents, e.g. eTMF
•Assist with eTMF reconciliation
•Execute eTMF Quality Control Plan
•Update manuals/documents (e.g., patient diaries, instructions)
•Document proper destruction of clinical supplies
•Prepare Investigator trial file binders
•Obtain translations of documents
Regulatory & Site Start-Up responsibilities:
Collaborate with other country roles to:
•In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
•Obtain, track and update study insurance certificates
•Support preparation of submission package for IRB/ERC and support regulatory agencies submissions
•Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Affairs (RA) where required per local legislation
Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
•Develop, control, update and close-out country and site budgets (including Split site budget)
•Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
•Track and report contract negotiations
•Update and maintain contract templates (in cooperation with Legal Department)
•Calculate and execute payments (to investigators, vendors, grants)
•Ensure adherence to financial and compliance procedures
•Monitor and track adherence and disclosures
•Maintain tracking tools
•Obtain and process FCPA documentation in a timely manner
Meeting Planning:
•The tasks may include but are not limited to coordinating meetings and site visits, tracking, managing, and analyzing study data, and preparing reports
•Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Qualifications, Skills & Experience
Skills:
•Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
•Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
•Hands on knowledge of Good Documentation Practices
•Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications
•Strong MS Excel skills required
•ICH-GCP Knowledge appropriate to role
•Excellent negotiation skills for CTCs in finance area
•Effective time management, organizational and interpersonal skills, conflict management
•Effective communication with external customers (e.g. sites and investigators)
•High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
•Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships
•Demonstrates commitment to Customer focus, both internally and externally
•Able to work independently
•Proactive attitude to solving problems / proposing solutions
•Positive mindset, growth mindset
Qualification & Experience:
•Completed job training (office management, administration, finance, health care preferred) or bachelor's degree
Compensation
The salary range for this role is: $68,000 - $107,000
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
Required Skills: Accountability, Analytical Problem Solving, Conflict Management, Customer Centricity, Customer-Focused, Data Analysis, Document Management, Growth Mindset, ICH GCP Guidelines, Microsoft Excel, Microsoft Office, Multitasking, Proactive Thinking, Project Management, Regulatory Compliance, Regulatory Submissions, Site Management, Supply Management, Time Management
Preferred Skills: Clinical Data Management, Clinical Documentation, Clinical Document Management, Clinical Trial Compliance, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Drug Regulatory Affairs
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Remote
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
