Senior Clinical Research Associate
Company: Galvanize Therapeutics, Inc.
Location: Pomona
Posted on: August 7, 2022
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Job Description:
Job Description Salary: Exempt; DOE The Senior CRA position is a
fully qualified role in clinical affairs requiring extensive
experience in the conduct of clinical trials. The Senior CRA works
with all members of Clinical Affairs, Regulatory Affairs, Quality
Assurance and Research and Development. This role also works with
personnel at clinical investigational sites on routine and complex
matters to accomplish proper study execution during all phases of
clinical trials. The position requires significant business travel.
The Senior CRA works under the general guidance of a Manager or
Clinical Study Manager. A person in this position may determine
his/her own objectives, independently plan work and develop
solutions to challenges in clinical affairs. The Senior CRA has the
experience to interact competently with investigational sites and
to handle complex assignments. Performance is evaluated on a
periodic basis for soundness of judgement and accuracy. Key
Responsibilities: Clinical Operations Leads a variety of
assignments related to study site management and other clinical
projects and systems Identifies and leads process improvement
projects Contributes significantly to the development of study
materials and review of eCRFs, EDC systems and source worksheet
creation Contributes to the development of clinical documents such
as clinical protocols, consent forms, clinical monitoring plans,
clinical study reports, annual regulatory reports, and clinical
reports/forms/SOPs/Work Instructions. Performs co-monitoring visits
as needed to ensure consistency and quality standards of monitoring
activities are being met with other contract and/or sponsor
monitoring team members Collaborates with other clinical staff and
departments to ensure the clinical studies are conducted in
compliance with Federal, State, and local regulations, Good
Clinical Practices and internal Standard Operating Procedures Helps
to define and develop clinical operations and programs efficiently,
cost effectively and with high-quality execution Responsible for
Interim Monitoring Visit Report review to ensure consistency of
monitoring and adherence to company SOPs across all sites per study
Provides study status update reports to the internal study team,
study sites, and external vendors. Tracks and provides updates to
study management on potential trends noted across multiple sites
and discusses potential strategies to remedy any potential issues
Escalates observed deficiencies and issues to clinical study
management and follows issues through to resolution Mentors,
trains, co-monitors and contributes to the growth/development of
junior clinical team members Clinical Monitoring Responsible for
making recommendations for site identification and selection
activities Manages site initiation, monitoring and close-out
activities for assigned investigational sites ensuring adherence to
applicable regulations, principles of ICH-GCP and SOPs Manages
assigned site activities through all phases of the clinical trial
including site qualification, site initiation, subject enrollment
and follow-up, and site close-out at assigned sites. Facilitates
and tracks site IRB/EC submission, approval, annual review, and
closure process at assigned sites Facilitates the negotiation of
clinical trial agreements and budgets Conducts protocol training
for investigators, study coordinators and other site personnel.
Ensures proper documentation of site personnel training and
delegation of Establishes and maintains regular contact with
investigational site personnel to ensure ongoing protocol
compliance, resolution of action items and queries, and accurate
and timely data entry Identifies, documents, and communicates
quality and/or compliance related issues in a timely manner to a
senior team member Ensures that study documentation is up to date
and audit ready at sites and within the study trial master file
(TMF) through periodic TMF QC checks. Coordinates, schedules, and
conducts monitoring visits at investigational sites to ensure
compliance to the clinical protocol, Federal, State, and local
regulations, the principles of ICH/GCP and internal standard
operating procedures Responsible for tracking and reconciliation of
investigational product inventory at assigned sites and study-wide;
follows-up with investigational sites Professionally represents the
company Develops and maintains cross functional and collaborative
relationships within the company and at investigational sites
Assists clinical study manager with other duties as needed Key
Requirements Education and Training Bachelor---s degree in life
sciences, medicine, or technical discipline preferred. Advanced
degree (MD, PhD, MS, DVM) and 1-2 years clinical research
experience, or BS and minimum 3 years clinical trial experience, or
5 years clinical trial experience, or Completion of a certification
program in clinical trial conduct and 3-5 years clinically focused
industry experience. Pulmonology experience preferred. Exceptional
experience/background in a particular scientific area that meets a
specific business need but with less clinical trial experience.
Skills and Experience Medical device research experience preferred.
Exposure to or experience with clinical monitoring activities
Superior knowledge of US and international clinical regulations and
guidelines Proficient in Microsoft Office with technical abilities
to become proficient quickly with numerous other electronic
systems. Detailed oriented, with solid organization and time
management skills. Able to work independently and in a team
environment. Complete projects with reliability and minimal
guidance Good communication skills with the ability to interact
with site personnel to ensure compliance. Travel: Ability to travel
up to 70%, domestically and internationally. Overnight travel is
required. Position Reports To: Clinical Study Manager
Keywords: Galvanize Therapeutics, Inc., Pomona , Senior Clinical Research Associate, Healthcare , Pomona, California
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