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CRA/ Site Support Liaison – Cebu

  • October 3, 2022

Clinitude is a sister company of Gemango Software Services Inc. is a Contract Research Organisation with headquarters in Belgium and Cebu is looking for junior CRA – CRA liaisons.

Candidates should engage in company training program to gain knowledge and skills required to independently support investigative sites if applicable and participate in clinical research. Collect, compile, document and support clinical research data via remote site support. May be responsible for the remote quality control of multiple projects. The Junior Site Support Liaison will need to comply with Good Clinical Practices (GCP), ISO14155, applicable regulatory guidelines, SOPs, policies and where applicable, guidance documents.

Responsibilities

  • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
  • With support, helps select the different research locations (site feasibility) and support the start-up of the clinical research (trial set-up), including providing support in establishing the necessary training regarding the protocol and legislation and regulations to the on-site staff at the research locations.
  • Document and track all communication (email, voice, fax, call reports) with study site personnel and client interactions, in accordance with study plans.
  • Under supervision, assists the practical implementation of clinical studies. This includes tasks such as preparing informed consent, ensuring appointments for the patient are made and communicated, preparing source documents,…
  • Ensure the site is recording data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources in accordance with study plans.
  • Follow established guidelines in the collection and entry of clinical data and resolution of data queries in accordance with study plans and client preferences. Under close supervision, evaluate and assure quality of data collected; ensure that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protection.
  • Assist the on-site team in the filing and archiving of clinical documentation according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.
  • Under close supervision, monitor site and subject progress, evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations, including documentation and reporting of adverse events; identifies and escalates need for corrective actions to manager and PI as appropriate.. Manage the progress of assigned studies by tracking recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
  • With support, creates and maintains appropriate documentation regarding site management, monitoring findings and action plans by submitting regular reports, generating required study documentation, if applicable and in cooperation with on-site CRA.
  • May support start-up phase.
  • If appropriate maintaining contact with the pharmaceutical company or external partner,
  • Under close supervision, may respond to questions on study procedures/protocol, if applicable in cooperation with the CRA
  • Supports on-site and remote monitoring as needed or other duties, as assigned. Ensure follow-up on action items, ensure follow-up applicable documentation.
  • Ensure clear communication with remote /on-site CRA if applicable.
  • Build awareness of features and opportunities of the study site.
  • Collaborate and liaise with study team members for project execution support as appropriate.

Required Knowledge, Skills and Abilities

  • Basic knowledge of, and skill in applying, applicable clinical _research regulatory requirements, i.e., GCP and ICH guidelines therapeutic and protocol knowledge as provided in company training Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
  • Good written and verbal communication skills
  • Strong interpersonal and organizational kills
  • Strong attention to detail
  • Effective time management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Minimum Required Education and Experience

Bachelor’s degree, in health care or other scientific discipline or educational equivalent and I year of on-site monitoring experience; or equivalent combination of education, training and experience.

Interested?

  • Call us at 032 415-5447
  • Clinitude is a sister company of Gemango Software Services Inc.
  • For more Info, please visit www.clinitude.com or Facebook page https://www.facebook.com/Clinitude

Additional Information

Career Level
1-4 Years Experienced Employee
Qualification
Professional License (Passed Board/Bar/Professional License Exam)
Years of Experience
1 year
Job Type
Full-Time

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Clinical Systems Coordinator – Belgium

  • September 26, 2022

The Clinical Systems Coordinator is responsible for the overall coordination and management of the set-up, implementation, design and maintenance, development and security of various clinical information systems including but not limited to Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and electronic Data Capture (EDC) systems, Electronic Health Record (EHR) among others.

  • In collaboration with the management, determines overall strategy in building and shaping the clinical systems and IT structure within the company.
  • Develops, maintains, and oversees applicable SOPs and templates to ensure that routine clinical systems operations are performed in adherence with ICH/GCP/regulatory guidelines and established best practices in collaboration with the Quality manager.
  • Advises on policies and latest trends on clinical systems and information security across the organization.
  • Manages projects to ensure effective integration of clinical systems as appropriate.
  • Leads in searching and selection of suitable system vendors.
  • Guides the team in the development and design of a compliant GxP in-house clinical system applications and tools and ensures validation of these tools.
  • Leads process improvement initiatives to streamline and standardize system processes.
  • Leads user training (internal and external) and train-the-trainer training sessions, establishing, and maintaining user reference materials for all user types.
  • Delegates task appropriately and coaches the team as needed.
  • Liaise with different system vendors for system updates and technical inquiries.
  • May participate in activities related to building study databases and applies advanced knowledge in the programming of complex CRF design, database building, edit checks, intermediate to complicated reports, custom programming, system interfaces and all system feature configurations.
  • May provide guidance /advice to customers on the selection, implementation, and management of clinical systems in accordance with the SOW.
  • May act as an administrator in the applicable clinical systems.

Skills and Qualifications:

  • Bachelor or master’s in computer science, software or application development or other IT related courses.
  • Proven experience in software and application development.
  • Working knowledge of clinical trial operations and/or clinical data management
  • Strong background of 21 CFR part 11 and GAMP5 is desirable
  • With good communication and interpersonal skills.
  • Familiarity with project management
  • Agile and with Can-Do attitude.
  • Affinity with lean principles
  • Passionate about technology and always go the extra mile to get the most suitable technological solution
  • Strong leadership and coaching skills

Your Education:

Bachelor’s degree, in health care or other scientific discipline or educational equivalent or equivalent combination of education, training and experience.

If you are interested, please send us your CV and motivation and get in touch with us at hr@clinitude.com

 

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We Are Looking For..

  • CRA/ Site Support Liaison – Cebu
    October 3, 2022
    Clinitude is a sister company of Gemango Software Read More
  • C# .Net Developer
    September 29, 2022
    We are starting new exciting projects and are looking to expand our current team of .Net Software Engineers. Read More
  • Great unwinding at Kalanggaman Island!Clinical Systems Coordinator – Belgium
    September 26, 2022
    The Clinical Systems Coordinator is responsible for Read More
  • Clinitude happyClinical Data Associate (CDA) – Cebu
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  • clinitude craClinical Research Associate Liaison (CRA LIAISON) – Cebu
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    Have you always been interested in how new drugs/devices are being developed, tested and registered? Clinitude, a long time partner of Gemango is looking to welcome you to become a part of the Cebu CRA team!Read More

Here in Clinitude…

We Work..

Our Belgian office starts its day at 9 AM and our Cebu office starts its day at 2PM, Mondays to Fridays

We Dress..

Business Casual

We Speak..

English

Our Benefits..

  • Personal growth possibilities
  • Above-Industry leave and travel benefits

A Sneak Peak at Clinitude..

Clinitude Valentine's Day 2020!
Valentine’s Day 2020! <3

We Are Located…

Europe Office

Belgium

Alfons Smetsplein 3H1

3000 Leuven

+32 16 58 19 84

US Office

Chicago

10 South Riverside Plaza

Suite 875, Chicago

Illinois, 60606

+1(0) 312 474 6080

Asia Offices

The Philippines

IT Tower 1, Rm. 14B

Ayala Business Park,

6000 Cebu

Empty This

Singapore

8 Marina View,

#43-01 Asia Square, Tower 1,

Singapore, 018960

+65 6407 1163

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