Avania are hiring - Clinical Trial Associate (CTA) in our Marlborough, MA office
Looking to gain more knowledge about the Clinical Trials industry? Consider joining Avania as a CTA and learn the skills needed for speedy promotion to a CRA role!
This role will be onsite in our Marlborough, MA office to help the selected candidate gain access to onsite SMEs for mentoring and guidance, fast-track through the training process and move more quickly to the next level - promotion to a field / traveling Clinical Research Associate role!
Avania's Clinical Trial Associate (CTA) primarily provides operational support to Clinical Research Associates (CRA), Lead CRAs (LCRA) and Project Managers (PM) and coordinates specified clinical trial activities. In this role, you will also provide assistance to Clinical personnel as required.
Our Clinical Trial Associate's (CTA) main responsibilities are to maintain the trial master files, ensure the quality and track the status of study documents, oversee study-specific trainings for team members, capture study-specific meeting minutes, produce study-specific binders, possibly interface with Sponsor representatives, suppliers, and site staff.
Specific duties include :
Study-Specific Documents and Files :
- Set-up and maintenance of TMF
- QC and review all study-specific documents received from sites, CRAs, etc. and coordinate
with sites and CRAs for additional documents. This may include peer-reviewing confirmation letters, formatting training presentations, and assisting with other review as requested.
Ensure TMF is audit and inspection ready.Assist with document processing, including completion / filing of deliverables, as necessaryParticipate in internal TMF reviews, as needed. (Assist in) the preparation of the study documents and binders, e.g. Study ReferenceManual, Investigator Site File / Regulatory Binder, Subject Binder and Screen Failure Binder.
Coordinate archiving of completed studies.Study-Specific Meetings :
Schedule and participate in project meetings, write and distribute meeting minutes.Prepare materials for meetings, as needed.Assist in organizing investigator meetings.Study-Specific Tracking and Inventory :
Keep study trackers / study progress overviews up to date.Oversee study-specific trainings for team members, ensuring appropriate documentation is obtained and filed.Administrative support with site payments.Coordinate the receipt, distribution, tracking and destruction of clinical trial supplies.Assist with the maintenance of monitoring tasks resulting from visits (e.g., adding tasks to necessary trackers, obtaining regular updates from CRAs, etc.).Department Activities :
Create PowerPoints and training binders for internal and external company trainings.Assist with creation of orientation presentations and training materials.Assist with internal training activities (e.g., setting up courses in Learning Management System, tracking training progress, etc.).Manage internal meeting agendas, sign in logs and complete minutes.Skills & Requirements
Candidates who offer any combination of the skills, knowledge and experience listed below, are encouraged to apply for the role of Clinical Trial Associate (CTA). With our continued growth we are hiring talent to join us on our journey and grow with us.
We seek -
B.A. or B.S. in a (para)medical, scientific or health related discipline or related work experience0-1 year of experience as Clinical Trial Associate (CTA).GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicableKnowledge of or ability to learn regulations and guidelines on medical devicesProficient in the use of computer and software systems and operation of office equipment, i.e., copier, scanner, printerStructured and detail-oriented with the ability to review and cross reference study-related documentsFlexible team player, with the ability to prioritize tasks and work under pressureStrong oral and written communication skills; fluent in English (spoken and written)As a CTA, there is minimal travel required; please note that once you are ready / promoted into a CRA I role - probably 6-12 months down the road - you will start traveling on a regular basis (including regular overnight travel each week)We offer -
The opportunity to work in an innovative, fast-growing, and rewarding industryA dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialtiesExchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunitiesCompetitive compensation and benefits package (details shared during the interview process)Some roles offer the opportunities for travelWe look forward to receiving your application!
Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status, or any other legally protected characteristic.
When you need to advance your career, it takes Avania!
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