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Clinical Trial Coordinator
2 months ago
Clinical Trial Coordinator (CTC)
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remote type
Hybrid
locations
THA - Bangkok - Bangkok (Tha-Central World)
time type
Full time
posted on
Posted Yesterday
job requisition id
R291477
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
CTC supports clinical supply & 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.
closely with COM, CRM and CRA.
Responsibilities include, but are not limited to:
- Trial and site administration:o Track (e.g. essential documents) and report (e.g. Safety Reports)
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management, in collaboration with other country roles
o Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
- Document management:o Prepare documents and correspondence
o Assist with eTMF reconciliation
o Execute eTMF Quality Control Plan
o Update manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Obtain translations of documents
- Regulatory & Site Start-Up responsibilities : Collaborate with other country roles to:o In a timely manner, provide to and collect from investigators forms/lists for site
site start-up and submissions
o Obtain, track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
o Publish study results for GCTO and RA where required per local legislation
Meeting Planning:
o Organize meetings (create & track study
memos/letters/protocols)
o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
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
- 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
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:
- Bachelor's Degree
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
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Clinical Trial Coordinator (Shipment clearance)
remote type
Hybrid
locations
THA - Bangkok - Bangkok (Tha-Central World)
time type
Full time
posted on
Posted 3 Days Ago
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.
Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
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