Oncology Clinical Research Associate
Company: Catalyst Clinical Research, LLC
Posted on: November 23, 2021
Catalyst is a clinical development organization providing highly
customizable clinical research solutions to the global
biopharmaceutical industry through two established solutions:
Catalyst Flex and Catalyst Oncology. Comprised of more than 500
members, our teams work to provide multi-therapeutic global
resourcing and functional services through Catalyst Flex, and a
full-service oncology CRO offering through Catalyst Oncology. we've
built our flexible service model from more than a decade of
listening to customers, devising customer-centric solutions, and
helping them drive breakthrough clinical development studies
leveraging our expert teams and innovative technologies.
We are looking for oncology focused CRA's in the Mid West that
would be comfortable with traveling to both East Coast and West
Monitors clinical trial programs and manages 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. Collaborates with
assigned clinical research team to provide input on site selection,
study initiation procedures, conflict resolution, and audit
responses. Effectively communicates 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
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
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
Excellent communication and interpersonal skills
Flexibility and ability to travel routinely to meet project
Strong knowledge of standard computer applications
Catalyst Clinical Research, LLC is an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive
environment for all employees.
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Keywords: Catalyst Clinical Research, LLC, Raleigh , Oncology Clinical Research Associate, Healthcare , Raleigh, North Carolina
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