We seek an experienced Senior CRA to complete activities of projects associated with the monitoring functions of the phase I-IV clinical research studies, while practically demonstrating mastery and a very deep understanding of the process of drug development, Good Clinical Practices (GCP), and the relevant regulations. The candidate would provide clinical and technical support for the Clinical Research Associates (CRA) I, II and II, and the administrative staff. The candidate would also perform the management of study site activities so as to ensure the integrity of the clinical data and in adherence to all the applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures. The qualified candidate for the job may also assume the role of Lead CRA (LCRA) on projects by directing and guiding the project team, coordinating all the monitoring activities, and communicate the statuses the activities to the Leader of the Study Project

Main responsibilities:

- Communication:
• Maintaining a timely and effective communication among the team members and the site staff
• Anticipating and identifying the potential issues routinely
• Independently implementing the corrective actions
• Keeping the leadership of projects apprised of the issues of the team, and seeking guidance whenever needed
• Demonstrating effective conflict resolution between team members

- Regulatory documentation
• Assuring that the local regulations, Code of Federal Regulations (CFR) or the International Conference of Harmonization (ICH) and GCP guidelines, the company and sponsor SOPs are complied with
• Maintaining an up-to-date regulatory documentation in accordance to the Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan
• Participating in TMF and on-site audits whenever requested Responding to findings without oversight
• Taking responsibility for submitting regulatory packages to the ethics committee and competent authorities
- Monitoring
• Taking responsibility for the management and staff performance of the site such as monitoring all the types of clinical trial
• Participating in all the types of site visitations
• Assuring all the protocol requirements are complied with
• Assuring that Adverse Events (AE) or Serious Adverse Events (SAE) and protocol violations are reported on time
• Ensuring that all Investigational Products and materials related to trials are properly stored, dispensed, and are accountable for
• Reviewing the status of the contents of the site regulatory binder regularly
• Exhibiting a superior time management skill
• Performing the assessments of and training visits with CRAs with lesser experience during the sign-off visits
- Handling data
• Performing verification of source data according to the requirements of the contract
• Assuring that the Case Report Forms are completed and submitted on time in accordance to the Clinical Monitoring Plan and Data Management plan
• Assuring that the Data Clarification Forms are accurately completed on time
• Monitoring proficiently with multiple data capture systems
• Performing reviews of clinical data listings as required
- Tracking and reporting
• Completing and submitting reports in accordance to the requirements of the sponsors or the Works instructions, which require minimal revisions
• Maintaining the awareness of the Key Study Performance Indicators for own sites, for example; Telephone Communications Reports, patient enrolment, and SAEs
• Updating the study and payment status information
• Serving as a resource of the Clinical Trial Management System for the Project Manager (PM) or the Lead CRA
• Tracking the payments and milestones of the investigator
• Documenting and tracking the resolution of all the site-specific issues related to protocol that are outstanding from visit to visit
- Administration
• Preparing for and attending meeting of the investigator meetings
• Attending Customer and Business Development meetings
• Presenting materials whenever requested
• Assisting in preparing study start-up materials and tools whenever requested
• Attending clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions in accordance to the communication, monitoring, and the training plans of the project
• Assuming the role as Lead CRA and assisting with the activities if the LCRA such as tool development, study plans, and team training
• Performing duties related to work as assigned
• Travelling extensively of more than 50% may be required

Requirements:

- A B.A or B.S Degree in the science or health care field, or a Nursing Degree or any equivalent combined education and field
- Experience in clinical monitoring
- An extensive understanding of SOPs, WI, FDA and the local regulations and the guidelines of ICH GCP, and an excellent understanding and application of applicable therapeutic standards
- Outstanding organizational, documentation, presentation and interpersonal skills, and the willingness to work within a team-oriented environment
- Proficiency in Microsoft Office Suite such as Word, Excel and PowerPoint, email, and voicemail
- A fluent command of communicating written and orally in a local language, if not English, and also English
- Ability to handle multiple tasks simultaneously in order to meet deadlines in a dynamic environment
- A valid and updated driver's license, and the ability to secure corporate credit card
- Certifications or credentials in ACRP CCRA or any equivalent is a plus