Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.
As a Senior Clinical Research Associate, you will monitor clinical trial programs and manage regional clinical trial sites to support biological and pharmaceutical developmental programs in a manner consistent with relevant regulations including ICH / GCP and PhRMA guidelines along with Catalyst Clinical Research’s applicable SOPs and working practices. You will collaborate with an assigned clinical research team to provide input on site selection, study initiation procedures, conflict resolution, and audit responses. You will effectively communicate all relevant and important findings with appropriate in-house personnel.
Specific responsibilities will include but are not limited to :
* Travels up to 80% within an assigned territory, monitors clinical trials according to monitoring plans to achieve project goals; conducts or assists with site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations. Develops territory to broaden selection of research study sites.
* Effectively communicates with site study staff and Catalyst clinical research personnel to report study site status, disseminate information to the appropriate individuals, and resolve study related issues; replies to audit findings.
* Partners with assigned clinical project team.
* Assists with Investigator Meetings planning / presentations, data collection, and FDA submission preparations.
* Maintains a home office if working remotely.
* Manages work activities in a time and cost-effective manner to ensure budgetary guidelines and project timelines are met.
* Participates in internal and / or external meetings to maintain current knowledge on applicable regulations and guidelines.
* Collaborates closely with the Study Manager and Project Manager.
* Internal support is provided to the Field Monitor from the assigned Clinical Trial Associate.
* Works closely with the extended study team including the Sponsor, Vendors, Data Manager(s), Statistician, Medical Monitor and other trial staff.
Qualifications :
* Bachelor’s degree in a science or health-related discipline or equivalent of 7 years industry experience.
* Minimum of 5 years’ experience in clinical research with direct site monitoring experience with a sponsor company or CRO and 3 years of recent oncology clinical trial experience.
* Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all applicable regulations and guidelines.
* Strong organizational and time management skills and the ability to work independently.
* Excellent communication and interpersonal skills.
* Flexibility and ability to travel routinely to meet project requirements.
* Strong knowledge of standard computer applications.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.
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