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