Clinical Research Associate Job

CLINICAL RESEARCH ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in East Hanover, NJ.

WHAT YOU'LL BE DOING:

- Act as Scientific and operational lead for execution of the US clinical trials within budget and in compliance with processes and regulatory requirements, with a strong emphasis on US customers and Health Authorities' requirements.
- Acts as US trial leader in the management and conduct of CAR T cell Therapy clinical trials within Oncology.
- Responsible for the execution of trial timelines, meetings, milestones, resources, eligibility, enrollment and data flow/consistency in alignment with Global Clinical Development.
- Creates working relationships with external site personnel and internal team coordinating activities across functions (investigators, study coordinators, US Medical, Global Medical, CROs, etc).
- Assist in the writing of trial related documents (eg Informed consents) and support documents for national IRB submission.
- Monitors and tracks trial progress and implements changes to ensure timely, quality deliverables.
- Responsible for the content of trial related communication to internal and external customers (eg newsletters, site/CRA trainings, protocol training).
- Responsible for the trial master file and study documentation according to SOPs/WPDs and GCP/ICH guidelines, ensuring no major audit findings.
- Addresses complex scientific trial related issues, particularly with biologic compounds, with internal and external customers
- Actively provides input in clinical trial protocols/reports and integrates feedback from internal and external partners.
- Oversight of data management activities of a trial and works with the CRAs/sites to ensure timely resolution of data issues.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor degree in science/nursing or equivalent
- At least 3-5 years of relevant pharmaceutical experience desired.
- Experience in clinical research involving biologic compounds.
- Well organized and has the ability to multi-task.
- Demonstrated problem-solving skills.
- Able to lead, manage and work in multifunctional teams.
- Ability to present scientific data both verbal and written to small and large groups frequently
- Previous experience in clinical trial/project resourcing, methodology, processes and operations
- Demonstrates effective interactions with appropriate levels of the organization and with an external audience.
- Project management experience desired
- Knowledge of GCP and regulatory requirements

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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MONJOB

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