Senior Clinical Research Associate (Sr. CRA)

Senior Clinical Research Associate (Sr CRA)

Brief Position:

The Senior Clinical Research Associate will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/ physician sites (either on-site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Clinixir and Sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements. Performs all tasks routinely and independently. Mentors and/or trains, as well as may assume line management responsibilities for less experienced employees. May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project.

Minimum Qualifications:

• Master's/ Bachelor's degree in pharmacy, nurse, life sciences (or equivalent) required
• At least 2 years of as a CRA and experience in monitoring in the pharma or clinical research industry. Experience in leading internal CRA is an advantage.
• Experience conducting Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
• Demonstrate knowledge of Thai and international clinical research regulations and guidelines such as ICH-GCP.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
• Demonstrate effective leadership and organization and communication skills.
• Ability to work proactively with challenging situations.
• Willing to travel upcountry (expected to be 40%, short period of time)
• Audit and inspection experience is a plus
• High energy, self-starter, agile, patient, creative problem solver with a curing desire to make a difference and drive Thailand's clinical research industry forward
• English proficiency level – intermediate to advance

Responsibilities:

• In collaboration with the study team (i.e. CRAs, SSU, PM), collect, track, maintain and reconcile essential documents and study trial files, according to the requirements of ICH GCP, local guidelines and Clinixir/ Sponsor SOPs.
• Co-ordinate and track transfer of data and documents between site, Clinixir and sponsor, i.e. CRF pages, data queries and essential document transfers as per sponsor requirements.
• Set up and maintenance of tracking systems to track study progress as designated by the Project Manager (PM) i.e. CRF & query flow, safety reports, CTMS, regulatory documents, contact records etc.
• Provide written and verbal site updates on study progress to the PM according to the study requirements/timelines.
• Co-ordinate distribution of study supplies to clinical sites, including tracking of clinical trial supplies (i.e. study drug, CRFs, IBs, Protocols, lab kits) according to study requirement. Ensure safe and orderly storage of study materials at Clinixir, and present stock reports as requested by the PM.
• Co-ordinate printing & distribution of protocols, Investigator Brochures (IB), Safety Reports for ethics/ regulatory submission as requested.
• Under guidance, and in collaboration with the study team (i.e. CRAs/ PM), track the reporting of study SAEs to the relevant stakeholders, i.e. Regulatory Authorities, Investigators, Sponsor according to the clinical monitoring plan.
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines (section 5.18). Specific duties include: Site Selection, Ethics & Regulatory Submission, Study Initiation, Monitoring Visits, Patient Safety, Data Collection, Site Documentation, Investigational Material and Close out & archiving.
• Understands project scope, budgets, and timelines for own and others activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
• Escalates site and trial related issues per Clinixir SOPs, until identified issues are resolved or closed.
• Provides guidance at the site and project level towards audit/ inspection readiness standards and supports preparation for audit/ inspection and required follow-up actions.
• Provide in-house support to the study CRAs whilst they are out on site, i.e. be able to contact study coordinators/ investigators on behalf of the CRA to request information or resolve issues. In-house support for submission of regulatory packages to ethics committees and/or competent authorities, site budget and clinical trial agreement (CTA) process.
• May act as primary liaison with study site personnel. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and co-monitoring/ accompany visits for junior CRA staff, as assigned.
• May be mentored and assigned lead tasks under supervision of an experienced Clinical Team Leader (CTL)/ Project Manager or operational line manager. This could include participation in business development proposals and/or defense meetings. Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy.
• Extensive travel may be required (more than 75%).

Workplace:

• Travel upcountry (expected to be 40%, short period of time)
• Extensive travel may be required (more than 75%).