The Clinical Trial Assistant (CTA) will support the clinical research team in the planning, execution, and management of clinical trials for medical devices. This role involves a variety of administrative and operational tasks to ensure the smooth and efficient conduct of clinical studies. The ideal candidate will have strong organizational skills, attention to detail, and a basic understanding of clinical trial processes and regulatory requirements.

Responsibilities:

• Provide administrative support to the clinical research team, including scheduling meetings, taking and distributing minutes, etc..

• Assist in the preparation, distribution, and tracking of clinical trial documentation, including protocols, informed consent forms, case report forms, and regulatory submissions.

• Provides support for document preparation and follow-up, and coordinates reviews for clinical documents

• Enter and maintain accurate data in internal tracking systems.

• Organize and maintain clinical files and under guidance from the Clinical Lead, perform QC of CRO’s TMF  to ensure that all documents are complete, accurate, and up-to-date.

• Assist in ensuring that all clinical trial activities comply with regulatory standards (e.g., FDA, EMA, ISO) and Good Clinical Practice (GCP) guidelines.

• Communicate with clinical trial sites and CRO staff to facilitate study start-up, monitor study progress, and ensure timely resolution of issues.

• Act as a point of contact for internal and external stakeholders, providing timely and accurate information related to clinical trials.

• Assist in the management and distribution of study supplies, including investigational products,  and study materials.

• Perform quality control checks on study documents and data to ensure consistency and accuracy.

• Assist in the preparation of training materials and facilitate training sessions for study staff and clinical trial sites.

• Prepare quarterly invoices for clinical trial sites based on data entered into the clinical database.

• Assist Clinical Lead with tracking of invoice payments for all sites and vendors

• Assist Clinical team with feasibility questionnaire reviews, site selection process, and on-boarding of new sites.

• Assist with investigator meeting and/or study coordinator meeting planning

• Performs other tasks or responsibilities as assigned by the Clinical Lead or VP of Clinical Affairs

Profile:

Education

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field; relevant certification or training in clinical research is a plus.

Languages

• Fluency in English, any other language is beneficial

Professional Experience

• Previous experience in a clinical research setting, preferably within the medical device industry is desirable

• Proficient in MS outlook, word, power point and excel

• Basic understanding of clinical study related documents

• Prior TMF experience with eTMF experience preferred

Soft Skills

• Excellent organizational and time management skills, with the ability to handle multiple tasks and prioritize effectively.

• Strong attention to detail and accuracy in all aspects of work.

• Effective written and verbal communication skills, with the ability to interact professionally with clinical trial sites, vendors, and team members.

• Ability to work with global teams utilizing different media (email, virtual meetings, teleconferences)

• Ability to work collaboratively in a team environment and contribute to a positive team culture.