CRA II TEXAS REGIONAL CLINICAL RESEARCH ASSOCIATE – Dallas

REGIONAL CLINICAL RESEARCH ASSOCIATE II - TEXAS
PHARMACEUTICALS

WE ARE SEARCHING FOR A FULL TIME CLINICAL RESEARCH ASSOCIATE II IN THE TEXAS AREA TO WORK FROM HOME SUPPORTING CANCER / ONCOLOGY CLINICAL TRIAL RESEARCH - IS THAT YOU?

This is a Permanent Direct Hire Position

What are we looking for ? A Clinical Research Associate [CRA] experienced in Oncology or Urology related pharmaceutical research who can work from their home / virtual office by assisting with coordination of clinical studies within the Clinical Operations area while demonstrating initiative and originality in organizing, systematizing and coordinating activities.

MUST HAVE:

1-BA or BS degree
2-Clinical research oncology or urology experience
3- 2+ years of direct clinical monitoring experience. This must be on the sponsor side (Pharma) monitoring and traveling to multiple sites. (Working in a hospital is NOT sufficient)

Our client is a leading edge biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of oncology and other drug candidates that meet critical health challenges for which there are few other treatment options.

The companys pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. The passion of the company to identify, develop and deliver better options for people suffering from cancer is behind every action they take.

What is in it for you?
Generous compensation, great people and a magnificent health, dental, vision, life, AD&D, and long-term disability insurance package, as well as Paid Vacation/Personal Days and a 401k plan with matching Company stock.

Responsibilities:
Demonstrate superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies.
Recognize the urgency of meeting established schedules and be able to prioritize tasks and time to meet those schedules.
Help manage and report on the conduct of clinical studies, as directed.
Help identify and select trial sites.
Conduct qualification, initiation, interim monitoring close-out visits, and perform drug accountability (approximately 50% travel required).
Ensure the timely collection of appropriate regulatory documents from study sites.
Develop materials that support the conduct of clinical studies including:
site reference manuals, monitoring flow sheets, CRF completion guidelines, etc.)
Review clinical documents for accuracy and completion (1572, informed consents, protocols, meeting minutes, etc).
Assist in the preparation of investigators meetings.
Participate as a member of project teams and coordinate efforts of other areas of the Company to support clinical project schedules.
Remain current with applicable regulations concerning development and conduct of human clinical trials (CFRs, ICH). Communicate to investigators the rudiments of GCP and their related responsibilities.
Demonstrate working knowledge of relevant clinical trial SOPs. Draft or revise Clinical SOPs as directed.
Ensure assigned studies adhere to approved protocols.
Maintain a level of accuracy that minimizes data query rate and ensures data are accurately transcribed to meet SOP and audit expectations. Identify and provide solutions for data trends.
Support other team members and facilitate team cohesion; play an active role in personal training and development needs.

Apply Here