Clinical Research Associate
JOB DESCRIPTION
Here at Moleac, we are a company aiming to address the needs of patient’s recovery from a loss of brain functions after a brain injury as well as cognitive deficits. In our small and dynamic Medical Affairs Department, you will play an important role in supporting the clinical studies we undertake and will have abundant opportunities to learn the entire clinical study process. The Department runs Moleac’s international drug development programs with two focus areas: extension of indications for our main marketed products and conduct of clinical studies aiming at the regulatory approval of our new products in major markets.
RESPONSIBILITIES
· Support the investigators in implementing clinical trials protocols:
o Liaise with the study site personal to implement the study per global and local requirements.
o Ensure compliance with all ethical, regulatory and contractual requirements.
o Training of study site personal (protocol, use of IP, SOPs, etc.).
· Ensuring data quality and integrity of clinical study data:
o Conducts site monitoring visits and follow-up to identify deviations & issues and to ensure that all clinical aspects of studies are being carried out in accordance with the protocol, regulations, guidelines and policies.
o Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance.
o Identifies deficiencies and discrepancies, and provides remedial training and/or implement corrective and preventive actions as required.
o Liaise with data management, reviews case report form queries, clarifies and/or obtains changes to data as appropriate.
· Create, update, track, and maintain study-specific trial management files. Ensure study documents are audit ready.
· Co-ordinate and track meetings with CROs, vendors, investigators and internal teams.
· Update and maintain clinical department management tools and systems, as required.
· Provide administrative support as required.
REQUIREMENTS
· Bachelor’s Degree in Science or a related field preferred.
· Minimum of 2 years’ CRA experience is preferred, however, other relevant experience and skills may be considered.
· Good understanding of GCPs (Good Clinical Practices).
· Advanced analytical thinking skills and numeracy grasp.
· Strong in using project management tools and Microsoft Office.
· High sense of accountability and urgency. Ability to set priorities and handle multiple tasks simultaneously.
· Meticulous, highly organized and effective in time management.
· Establishes and maintains good working relationships with internal and external stakeholders (e.g., investigators, trial coordinators and other site staff).
· Fluent in English (verbal and written) and excellent communication skills.
APPLICATION PROCESS
Please send the following to [email protected]
> Cover letter
> Resume
> Expectations: Salary
> Availability
