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Clinical Trial Coordinator

2 months ago

Rahway, New Jersey, United States Msd Malaysia Full time
Clinical Trial Coordinator (CTC) page is loaded

Clinical Trial Coordinator (CTC)

Apply

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.

The role will collaborate at local level
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 Ensure collation and distribution of study tools and documents
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 Collate, distribute/ship, and archive clinical documents, e.g. eTMF
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
evaluation/validation,

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
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:

  • Bachelor's Degree
Current Employees apply HERE
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):
Similar Jobs (1)

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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