Senior CRA Flex

Novotech; Manila; Hybrid; PHP 600,000 - 1,000,000; Full time

Job summary

Novotech in Manila is seeking a Senior Clinical Research Associate I Flex to monitor clinical sites, contribute to protocol and ICF development, and ensure ICH-GCP compliance across projects.

The role involves site qualification, initiation, interim monitoring, close-out visits (on-site or remote), data integrity review, sponsor communications, training junior CRAs, and preparing for audits.

Qualifications

• BS degree in life sciences or equivalent required.
• Minimum 5 years in clinical research.
• Fluent written and spoken English; additional languages a plus.
• Strong organizational and communication skills.
• Good knowledge of ICH-GCP guidelines.

Responsibilities

• Perform site qualification, initiation, interim monitoring, and close-out visits.
• Monitor adherence to protocol, ICF, and regulatory requirements.
• Evaluate site performance and communicate action plans to the team.
• Lead and participate in investigator meetings and training sessions.
• Support audit readiness and CAPA development.
• Provide mentorship to junior CRAs when needed.

Skills

English proficiency

Site monitoring

Documentation

Communication

Attention to detail

Mentoring

Education

BS degree in life sciences

Job description

Position Title: Senior Clinical Research Associate I Flex

Responsibility :

• Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
• Perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team and develop action plans. Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrate diligence in protecting the confidentiality of each subject/patient. Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings. Participate, and may, with supervision, lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project-specific requirements.
• Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
• May provide training or mentorship to more junior level CRAs. May perform training and sign-off visits for junior CRA staff, as assigned.
• May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
• As required, collaborate and build relationships with sponsor and other affiliates.

Qualifications :

• A 4-year BS (Bachelor of Science) degree or equivalent experience. Advanced degree is a plus.
• At least 5 years of experience in a clinical research environment.
• Good command of written and spoken English or another second language.
• Good organization and communication skills.
• High attention to detail and accuracy.
• Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs