Clinical Trials Associate (12-month contract)

About the role

This role will be located in Dublin, IRE OR Bellevue, WA and is hybrid with a minimum of 3 days per week onsite. This is a 12-month fixed term position.

Responsibilities

• Provide administrative support to clinical trial teams.
• Afford assistance in the preparation and maintenance of essential trial documents.
• Organize internal study team meetings and issue agendas/minutes (with approval from CTM).
• Assist and support eTMF Manager in QC of eTMF.
• Set up and ensure all study-related documents are filed per folder structure on internal filing repository (Sharepoint).
• Afford oversight to internal study conduct tracker, and any other oversight trackers up-to-date.
• Maintain study conduct metrics, including but not limited to study start up timelines, enrollment rates, screen-failure rates and deviation rates.
• Monitor review oversight of external vendor.
• Participate in patient data review in collaboration with cross-functional teams and external vendor.
• Afford assistance in reviewing invoices, including pass-throughs, referring to site agreements, patient enrollment and/or monitoring visit trackers.
• Carry out the function of the role in compliance with company Standard Operating Procedures (SOPs), working practices and regulatory guidelines.
• Foster effective and collaborative working relationships with cross-functional teams and management globally to ensure trial milestones are met.
• Promote timely and accurate communication amongst the internal and external teams.
• Serves as back-up to the CTM, when needed.

Requirements

• Bachelor’s degree preferably in the field of biology, chemistry or health sciences and 1-3 years’ previous clinical research experience.
• Prior Clinical Trials Associate experience in oncology preferred.
• Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional and global team. Ability to establish and maintain effective working relationships.
• Good organizational skills and the ability to work effectively in a high paced, fast changing, compliance-driven environment. Results-oriented and flexible attitude.
• Ability to track and manage key dates/deadlines.
• Basic knowledge of drug development and FDA GCP regulatory guidelines.
• Familiarity with FDA/ICH regulatory requirements for clinical trials is desired.
• Excellent oral and written communication skills, with particular attention to detail.
• Ability to appropriately handle confidential information.
• Proficiency with MS Office and Excel.

Qualifications

• Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional and global team. Ability to establish and maintain effective working relationships.
• Good organizational skills and the ability to work effectively in a high paced, fast changing, compliance-driven environment. Results-oriented and flexible attitude.
• Ability to track and manage key dates/deadlines.
• Basic knowledge of drug development and FDA GCP regulatory guidelines.
• Familiarity with FDA/ICH regulatory requirements for clinical trials is desired.
• Excellent oral and written communication skills, with particular attention to detail.
• Ability to appropriately handle confidential information.
• Proficiency with MS Office and Excel.

Skills

• Strong organizational and administrative skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Knowledge of clinical trial processes and regulatory guidelines.
• Proficiency with MS Office and Excel.

Benefits

We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.

Pay

The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).