Clinical Trial Assistant
Clinical Trials Assistant (I/II) - Anywhere, EU Anywhere, EU Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Clinical Trials Assistant provides administrative and trial support to the Clinical Operations and Project Management departments, thereby contributing to the overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs). Responsibilities of the role will be focused in Finance/Site Payments as highlighted below. Must have an interest or experience with numbers or finance to be considered. Work experience required, with CRO or Pharma experience highly preferred. Specific tasks would include:
- Interfaces with Client representatives and SynteractHCR study team to ensure timely initiation and completion of clinical trials.
- Assists study teams with selective aspects of trial management from start-up to close-out on one or more studies.
- Provides support in creating the Trial Master File (TMF) and/or Investigator site files; with oversight, assists with maintenance tasks such as filing for the duration of the study, and with preparation for audits and archiving.
- May assist with maintaining and updating project-related data in an existing database, i.e. CTMS, EDMS, etc., which involves contacting internal team members to gather information.
- Assists with the preparation of study-related correspondence, including but not limited to: meeting minutes, tracking spreadsheets and presentations with some direction and an acceptable degree of accuracy.
- Assists in the receipt, collection, tracking and review of essential documents to confirm completeness.
- Creates project-specific binders and binder tabs as instructed; may coordinate the distribution of clinical trial materials (e.g. regulatory binders); ensures inventory is adequate for the overall study.
- May assist with the translation process of study documents.
- Assists with processing of clinical investigator payments, client/vendor invoices, study expense reports and other financial items, which may include interaction with the study team and accounting.
- May assist with ensuring finalized clinical trial agreements/contracts are properly tracked, maintained, filed and forwarded to the sponsor/clinical site.
- May participate in the testing of potential new software or equipment.
- Arranges catering for department/company luncheons, client luncheons and occasionally dinner as necessary.
- May contribute to the planning, organization and execution of company wide events.
- High school/secondary level education required with work experience in a related field. CRO or Pharma exper highly preferred.
- Basic IT proficiency and skills including Microsoft Office.
- Effective verbal and writing skills; English + local language, if relevant