Clinical Trials Associate I

Our FSP team is currently seeking an CTA to join our growing team! Candidates must be within the United States.

Job Overview:

The Clinical Trial Administrator (CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the CTA shall reflect their experience, and level of contribution which they can make to the project. The CTA performs study-related tasks as required by the department, including (but not limited to): communicate with project team members regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide systems support, track information related to the status of study activities and assist with general administrative functions as required. Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable.

Summary of Responsibilities:

• Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
• Assist in the preparation of study and site-specific materials in accordance with relevant SOPs.
• Complete minute taking and documentation for sponsor/external or internal teleconferences as requested.
• Assist in setting up and maintaining tracking systems/spreadsheets for e.g., study supplies.
• Maintain the Project Directory.
• Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting.
• Provide support to project team (e.g., proof-reading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.).
• Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable.
• Audit and CAPA tracking.
• Set up and maintain clinical investigator files and documentation.
• Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members.
• Coordinate and plan study supply shipments with vendors.
• Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery.
• Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e., diary cards, patient visit reminders).
• Generate reports as needed, for example CTMS site contact information list.
• Work with the In-House CRA and other project team members on reconciliation of data with CTMS.
• General communications to sponsors, sites and internal team members via electronic mail or courier or telephone.
• Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelor’s degree in the life sciences or related field; or Associates degree in the life sciences or related field and 2 years of relevant experience in lieu of Bachelor’s degree.
• Speaking English and local language.
• Writing/Reading English and local language.

Experience (Minimum Required):

• Minimum one (I) year administrative experience or equivalent training.
• General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines.
• Good oral and written communication skills.
• Good organizational and time management skills.
• Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint).
• Aptitude for handling and proof-reading numerical data, some spreadsheet software competency.
• Good typing skills.
• Good spelling and proof-reading skills.
• Ability to operate standard office equipment (e.g., fax, copier).
• Works efficiently and effectively in a matrix environment.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

The important thing for us is you are comfortable working in an environment that is:

• Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.

• Changing priorities constantly asking you to prioritize and adapt on the spot.

• Teamwork and people skills are essential for the study to run smoothly.

• Technology based. We collect our data directly into an electronic environment.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

• Target Pay Range: $45-50k USD

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.