Likak Research recruits 01 Senior Clinical Research Associate
Scope of role
Conducts monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapreutic areas. Ensures that clinical research studies are conducted in accordance with the protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulatory requirements.
Responsibilities
- Performs site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and Good Clinical Practice.
- Provides monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administers protocol and related study trainings to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherance to applicable regulations. Escalates quality issues to Likak Manager and/or Project Manager (PM).
- Manages the progress of assigned studies by tracking regulatory submission and approvals, recruitement and enrolment, case report from (CRF) completion and submission, and data query generation and resolution.
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and actions plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Acts as a mentor for clinical staff including conduction of co-monitoring and training visits.
- May provide assistance to the Clinical Project Manager with design of study tools, documents and processes.
- All responsibilities are essential to job functions unless noted as non-essential (N).
Reports to: Likak Manager, Project Manager or Designee.
Required knowledge, skills and abilities
- In depth knowledge of, and skill applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- In depht therapeutic and protocol knowledge as provided via company training
- Computer skills including proficiency in use of Microsoft Word, Excel and Powerpoint and use of laptop computer.
- Strong written and verbal communication skills, including good command of English language.
- Excellent organizationnal and problem-solving skill.
- Effective time management skills.
- Ability to manage competing priorities.
- Ability to establish and maintain effective working relatonships with co-workers, managers and clients.
Qualifications and experience
Education
Bachelor’s degree in a health care or other scientific discipline or educational equivalent.
Experience
Minimum of 5 years of onsite monitoring experience; or equivalent combination of education, training and experience
Language
Fluency in English and Portuguese is required.
Application
All CVs and Motivation Letters should be sent to the following email: recruitment@likakresearch.com
Closing date : 2 June 2022.