Clinical Research Associate

  • Sector: 医院&保健
  • Contact: Cherry Anne Santos
  • Contact Email: cherry@monroeconsulting.com.ph
  • Location: Makati City
  • Salary: PHP50000.00 - PHP60000.00 per month
  • Expiry Date: 22 August 2022
  • Job Ref: BBBH395277_1655961496

Post Job to:

Monroe Branch:

Philippines

Template to use:

Healthcare

Department

Clinical Research Associate (CRAI/ CRAII)

Industry

Digital Health

Salary

Php 50,000-Php 60,000

Years of Experience

At least 2 to 3 years of experience as CRA

Location

Remote work

Education Level

Bachelor's degree in life science, chemistry, or health is preferred.

Company & Job Description

Clinical Research Associate (CRAI/ CRAII)

Executive recruitment company Monroe Consulting Group Philippines is recruiting on behalf of a multinational company that provides consulting and clinical trial support services for companies without entities in SEA. Our respected client is seeking a Clinical Research Associate that will handle the Philippine market. The candidate will work remote.

Job responsibilities:

Clinical Development Operations

· Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects' rights, safety and well-being are being protected.

· Primary point of contact of trial sites with regards to the conduct of the study/ project

· Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work

· Ensure that the sites are adequately trained on the protocol and other study specific requirements

· Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan

· Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF).

· Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.

· Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.

· Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)

· Track site budget and payments

· May be involved in preparation of status reports for clients

· Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary

· Act as mentor/coach to more junior staff as necessary

· Travel as necessary according to project needs

· Perform other duties as assigned by line manager

Regulatory:

· Ensure study start up processes are done according to applicable SOPs and regulatory requirements

· Prepare and submit regulatory and clinical documents to Regulatory Agencies and Independent Ethics committee (IEC)/Institutional Review Board (IRB)

· Ensure that product labels are compliant with applicable regulatory requirements

· Collect and submit necessary documents for study drug importation, return and/ or destruction

· Ensure that all documents necessary for site activation are collected

Job Requirements

· Bachelor's degree in life science, chemistry, or health is preferred.

· ICH-GCP training is required

· Relevant experience on conduct of clinical trials and on-site monitoring

· Excellent communication, both written and verbal, and interpersonal skills

· Fluency in English is required

· Proficiency in MS Office program

Signature

All applications will be treated in the strictest of confidence. If you are a suitable match for this position please send your application