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Clinical Trial Associate
- Clinical Operations
- Houston, TX, USA
- Full Time
In this interesting, full-time position you will work on all operational activities to support the Clinical Trial Manager and Study Team with all trial related activities from study start-up to close out. You will prepare and maintain study specific tools to ensure continuous oversight of the study progress. A crucial part of the job is the management of trial specific TMF (setup, maintain, archival) including site regulatory document and legal document tracking and archiving throughout the duration of the clinical trial in accordance with SOPs, ICH GCP guidelines and applicable local governance laws.
He/she must be self-motivated, pro-active and flexible. This position is office based if applicable. This position reports to the Global Director Clinical Operations.
- You have a minimum of 2 years of experience in clinical trial management and methodology from study start-up to closure.
- Your experience as CRA (working for CRO or sponsor company) would be an advantage. You have a detailed knowledge of Clinical Trial Process, including ICH/GCP guidelines (ICH GCP accreditation would be a plus)
- You have experience in TMF set-up, maintenance and periodic reviews.
- You have experience in review and tracking of regulatory documentation for successful implementation of clinical trials.
- You are experienced in identifying potential deficiencies in the trial progress and assisting in creation and resolution of the Corrective Action Plan.
- You exhibit excellent organizational and record-keeping skills
- You are a self-motivated, pro-active driven and flexible personality
- Bachelor's degree in Nursing, Medicine or other Life Sciences or RN degree from an accredited school
- Minimum of 4 year experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable)
- Familiarity with regulatory affairs in Europe
- Familiarity with clinical research in Oncology
- Familiarity with Medical Device regulations or clinical trials
- Understanding of the European legislation governing clinical trials and GCP
- Accredited GCP course
- Fluency in English (verbal and written) and excellent communication skills
- Strong critical thinking and problem solving skills
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
- Excellent organizational and record-keeping skills
- Ability to maintain excellent working relationships with a broad range of trial staff
- Ability to work well in a team environment but also independently without significant oversight
- Flexibility in work hours and readiness to travel abroad on a routine basis
- Advanced computer literacy
Patient-forward: aspiring to make a difference in cancer.
Our patient-forward mission
Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
Our patient-forward values