We are seeking a skilled and motivated Clinical Trial Associate to join our dynamic team.
As a Clinical Trial Associate, you will play a crucial role to support the management of clinical trials from study start up through to study close out, in accordance with relevant regulations, SOPs, and study specific procedures.
The successful candidate will be responsible for coordinating trial activities and collaborating with cross-functional teams to deliver high-quality results.
This is a unique opportunity to join a cutting-edge Biotech company, focussed on driving synergies across all aspects of R&D and operations to develop transformative medicines.
Roles and Responsibilities The Clinical Trial Associate will be responsible for assisting the Clinical team with the day-to-day coordination required in the running of clinical trials.
Activities will include but are not limited to, collaborating with vendors to ensure sample integrity, filing of study documents in the study Trial Master File, coordination of Sponsor data reviews, tracking of study activities and ensuring clinical trial registries are maintained:
Documentation and Reporting:
Maintain accurate and complete trial documentation, including submission of essential documents to trial master files.
Collaborate with cross-functional teams to support clinical deliverables including the distribution of study documents Support the review coordination of clinical documents (i.e.
Protocol, IB, ICFs and study manuals) Maintain information on clinical trial registries Sample logistics:
Work closely with lab vendors and translational internal team to ensure end to end sample and lab data integrity for patient samples.
Proactively communicate with CRO or sites related to planned patient visits to ensure adequate supplies available Liaise with vendors and couriers where necessary to resolve shipping issues Track samples for global clinical trials Data Collection and Tracking:
Coordinate internal Sponsor data reviews including following up on resolution of QC findings.
Create and maintain study tracking of documents as needed Regulatory Compliance
Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, other training requirements, and study specific procedures and training Complete all GXP training relevant for the role Other Operational Aspects Support Clinical Team with the organisation of study Contribute to clinical study team meetings (face-to-face or virtual).
Work cross-functionally with internal teams and external vendors, and assist wider team with any activities which support trial management Proactively keep clinical team and manager informed about work progress and any issues Qualifications and Experience Bachelor's degree in a scientific or healthcare-related field Proven experience supporting clinical activities Good Microsoft Office (Word, PowerPoint, and Excel) skills Some knowledge of regulatory requirements and guidelines governing clinical trials Required Competencies Strong organizational and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and collaboratively in a fast-paced environment Motivated to develop and learn Flexible and adaptable team player, who actively contributes to the team High level of accuracy and attention to detail Willingness to do what needs to be done Live and promote the company values