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.