Associate Clinical Research Scientist
Description
The Associate Clinical Research Scientist (ACRS) supports the execution of the clinical studies that make up the company’s clinical evidence generation program. In this role, you will support and facilitate the execution of clinical studies and/or programs worldwide under the direction of a CRS or Sr CRS, and in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
The ACRS interacts and liaises closely with the cross-functional teams, including CRS and Sr CRS, Disease State Scientists, Data Management and Biostatistics, Regional Medical Affairs teams and other stakeholders to facilitate, review, and provide input to study documents, strategies and plans.
The ACRS may have responsibility for clinical monitoring activities under the supervision of CRS/Sr CRS and for liaising with external vendors.
This role is crucial in maintaining our commitment to clinical research excellence and patient-centric approaches.
This role can be located in either St. Louis, MO OR Salt Lake City, UT.
Primary Duties
Study Documentation, Planning, Strategy and Reporting:
a. Supports the CRS or Sr CRS in the collection and delivery of documentation to meet study milestones and performance, including study plans for non-registration Investigator Initiated Research (IIR), clinical study project plans, study execution plans, risk and risk mitigation plans, and monitoring plans.
b. Responsible for study documentation filing in corporate systems and according to GCP guidelines
c. Contributes to the development, documentation, and management of study budgets and timelines, as directed by the CRS or Sr CRS
d. Reviews and provides input to the development of IIR/CIR study protocols
e. Assists in compiling monthly status and dashboard reports
a. Supports the CRS or Sr CRS in the collection and delivery of documentation to meet study milestones and performance, including study plans for non-registration Investigator Initiated Research (IIR), clinical study project plans, study execution plans, risk and risk mitigation plans, and monitoring plans.
b. Responsible for study documentation filing in corporate systems and according to GCP guidelines
c. Contributes to the development, documentation, and management of study budgets and timelines, as directed by the CRS or Sr CRS
d. Reviews and provides input to the development of IIR/CIR study protocols
e. Assists in compiling monthly status and dashboard reports
Study Management and Site Management:
a. Assists in the management of IIR studies from proposals submission to study close-out.
b. Supports the project team in the management of aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out for BIR / CIR studies as directed by the CRS or Sr CRS
c. Facilitates tracking of study progress and provides regular status reports to the study team
d. As directed, input study and site information, metrics and budget tracking information into relevant BioMérieux systems
e. Updates trial management systems, including timelines and budgets Contribute to site selection, feasibility, study startup, site activation, enrollment, and ongoing execution
f. Manages the coordination of logistics and training needed to execute studies
g. Conducts clinical monitoring as directed and required including on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits
h. Supports the CRS / Sr CRS in overseeing clinical site activities, reference laboratories, contract research organizations (CROs), and other external partners to ensure adherence and compliance with protocol timelines, budgets, study milestones and quality standards
i. Supports and coordinate IRB/EC document creations and communications
j. Supports the execution of clinical trial agreements for sites
a. Assists in the management of IIR studies from proposals submission to study close-out.
b. Supports the project team in the management of aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out for BIR / CIR studies as directed by the CRS or Sr CRS
c. Facilitates tracking of study progress and provides regular status reports to the study team
d. As directed, input study and site information, metrics and budget tracking information into relevant BioMérieux systems
e. Updates trial management systems, including timelines and budgets Contribute to site selection, feasibility, study startup, site activation, enrollment, and ongoing execution
f. Manages the coordination of logistics and training needed to execute studies
g. Conducts clinical monitoring as directed and required including on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits
h. Supports the CRS / Sr CRS in overseeing clinical site activities, reference laboratories, contract research organizations (CROs), and other external partners to ensure adherence and compliance with protocol timelines, budgets, study milestones and quality standards
i. Supports and coordinate IRB/EC document creations and communications
j. Supports the execution of clinical trial agreements for sites
Regulatory Compliance:
a. Follow Corporate (e.g., SOP’s) and local/regional regulatory requirements
b. Participates in the review and revision of Clinical Operations Standard Operating Procedures (SOPs) to assist Medical Affairs leadership with continuous process improvement initiatives
a. Follow Corporate (e.g., SOP’s) and local/regional regulatory requirements
b. Participates in the review and revision of Clinical Operations Standard Operating Procedures (SOPs) to assist Medical Affairs leadership with continuous process improvement initiatives
Quality and Compliance:
a. Supports the team as directed in managing risks throughout the clinical trial lifecycle
a. Supports the team as directed in managing risks throughout the clinical trial lifecycle
Data Management:
a. Participates in the setup and management of electronic data capture (EDC) systems
b. Assists in data collection and data clarification activities as directed
c. Supports any inspection readiness activities as directed by the CRS / Sr CRS
a. Participates in the setup and management of electronic data capture (EDC) systems
b. Assists in data collection and data clarification activities as directed
c. Supports any inspection readiness activities as directed by the CRS / Sr CRS
Communication:
a. Assists in the conduct of internal and external study meetings as directed
b. Communicates with cross functional team members regarding study status, issues and reporting
c. Participates in core team meetings to provide input
a. Assists in the conduct of internal and external study meetings as directed
b. Communicates with cross functional team members regarding study status, issues and reporting
c. Participates in core team meetings to provide input
Vendor management:
a. Assists in the negotiation of clinical trial agreements, contracts, and budgets of with external vendors in partnership with the legal team and as directed by the CRS / Sr CRS
a. Assists in the negotiation of clinical trial agreements, contracts, and budgets of with external vendors in partnership with the legal team and as directed by the CRS / Sr CRS
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.
Experience
- Bachelor degree required in scientific, medical, or healthcare discipline
- No previous experience required
- Knowledge of clinical trial processes, and training in Good Clinical Practice (GCP) guidelines and regulatory compliance (FDA and ICH guidelines).
- Certifications including CCRA (certified Clinical Research Associate) or CCRC (certified Clinical Research Coordinator) a plus.
- Prior experience working in clinical operations or in clinical trial conduct, including work such as a clinical research associate (CRA), clinical trial assistant (CTA), clinical research coordinator (CRC), or clinical trial manager (CTM).
- Experience in clinical trial documentation and processes.
- Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) tools, and regulatory documentation is preferred.
- Prior experience in Medical Devices, Diagnostics, Pharmaceutical, Biotech or in a Contract Research Organization (CRO) environment is preferred.
Knowledge, Skills, & Abilities
- Acting with Honor and Being Open Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
- Being_Organizationally_Savvy Ability to cooperate with others at all levels including leadership
- Communicating_Effectively Effective verbal communication skills
- Getting_Organized Organizing work and resources efficiently to ensure smooth operations
- Intellectual_Horsepower Detail orientation to complete tasks without errors and produce high-quality work.
- Maintaining_Focus Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
- Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance
- Functionally Required Knowledge, Skills, and Abilities
- Ability to manage budget, timelines and multiple projects simultaneously
- Ability to learn new products and adjust to changing research directions
The estimated salary range for this role is between $70,000 and $91,200. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
In addition, bioMérieux offers a competitive Total Rewards package that may include:
· A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
· Company-Provided Life and Accidental Death Insurance
· Short and Long-Term Disability Insurance
· Retirement Plan including a generous non-discretionary employer contribution and employer match.
· Adoption Assistance
· Wellness Programs
· Employee Assistance Program
· Commuter Benefits
· Various voluntary benefit offerings
· Discount programs
· Parental leaves
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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).