Clinical Trial ​Assistant

Position ​Overview

- ​Support the ​clinical operation team under ​the ​supervision of ​Sr. Clinical Operation ​Manager.

- ​Assist ​with the ​review, ​tracking ​and monitoring the ​day-to-day ​aspects of clinical ​trials ​and ​ensure clinical trial ​documents are ​collected, ​recorded, and ​filed.

- ​Ensure ​clinical trials are ​conducted in ​accordance with the protocol, standard operating procedures, ICH/GCP, and all applicable regulatory requirements

Responsibilities

- Maintain the Trial Master File

- Will adhere to applicable SOPs, Wis, policies, local regulatory requirements, etc.

- Complies with relevant training requirements

- Review and track progress of clinical trial, essential regulatory documentation from clinical sites before study start-up and throughout study conduct, such as financial disclosures, debarment checks, current CVs, GCPs, relevant certification and licensing requirements. Collect and file all documents throughout the trials and post-trials activities. Support TMF quality control and reconciliation

- Collect and prepare documents required for study, such as start-up/submission to the IEC/IRB, in support of the CPM/Sr. CRA where applicable.

- Prepare study files for investigational sites and coordinate the development of associated documents and review them for completeness and accuracy

- Maintain trial, country and site level protocol information in trial management systems

- Manage study data, budge and payments, investigational products, mailing and correspondence and other relevant tasks in support of the CPM and Sr. CRA

- Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational sites within required timeframes

- Accountability of IP: partner with the internal/external team for IP shipment and transfers. Ensure accountability records are accurate from receipt through final disposition

- Coordinate archiving of study relevant documents/files

- ensure audit and inspection readiness

- Assist with user acceptance testing of eTMF and databases

- Assist in the development of case report forms and case report form completion guidelines (CCGs)

- Provide process improvement suggestions if applicable

- Provide updates to study specific internal data repositories to ensure availability of trial documents to the study team

- If requested, organize training for SIVs or small investigator meetings

- Assist clinical operation team with gathering agenda topics, preparing agenda, scheduling meetings, liaise with meeting planners, and coordinate logistics for internal or external meetings

- Attend, participate, prepare, and distribute meeting minutes and action items for both internal and external meetings

- Support preparations and response to audits, internal review, documentation, etc.

- Review Site Visit Reports for accuracy, quality and consistency

- assist with managing study vendors

Qualification:

- Education: BA/BS degree in Life Sciences, Nursing or related scientific field.

- Required Experience:

- 2+ years of relevant clinical trial experience with associated skill sets in oncology trials

- Previous experience in the pharmaceutical industry/biotech (plus)

- Knowledge, Skills and Abilities:

- Proficient in English (spoken and written)

- Strong knowledge of MS office (Word, Excel, and PowerPoint) and Adobe Acrobat

- Strong interpersonal skills

- Excellent organizational skills and the ability to collaborate and handle multiple priorities within a fast-paced environment

- Perform activities in a timely and accurate manner

- Strong attention to detail is a must

- Able to work in a fast-paced, evolving biotech environment with focus on quality

- Able to work flexible hours considering the time zone differences across Asia and the US

Other Information/Additional Preferences

- Applicants who are eligible to work in Boston are preferred.

- While this is a remote position, two days in the office per week are mandatory.