Senior Clinical Research Associate I Flex

Novotech Health Holdings; Philippines; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Novotech Health Holdings is seeking a Clinical Research Associate (CRA) to manage and monitor clinical projects in line with ICH-GCP, SOPs, and PMP. You will contribute to protocol development, perform site qualification/monitoring visits (onsite or remote), and ensure regulatory compliance across study sites.

The role requires a BS in a science field, 3+ years in clinical research, strong English communication, and meticulous attention to detail.

Qualifications

• 4-year BS degree or equivalent.
• Advanced degree is a plus.
• At least 3 years of experience in clinical research.
• Good command of written and spoken English.
• Good organization and communication skills.
• High attention to detail and accuracy.

Responsibilities

• Contribute to protocol and ICF development and other documents.
• Perform site qualification, initiation, monitoring and close-out visits (on-site or remote).
• Ensure regulatory, ICH-GCP and project requirements are met.
• Escalate serious issues and support action plans with the team.
• Provide training or mentorship to junior CRA staff as needed.

Skills

English proficiency

Communication skills

Organization skills

Detail-oriented

Education

Bachelor of Science in related field

Advanced degree preferred

Job description

Clinical Research Associate (CRA) Job Description The Clinical Research Associate (CRA) is responsible for managing and monitoring the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP), and applicable Project Management Plan (PMP) and local regulatory requirements. Job Responsibilities

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 3 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.