Clinical Research Associate
Job Summary
The Clinical Research Associate assists in the administrative of clinical research projects including development of key study documents, oversite of the clinical trial, and ensuring the quality and integrity of the data according to GCP, ICH and SOPs.
Key Duties
Monitor case report forms and electronic data for quality, completeness, and accuracy
Interact with data management and study sites with generation and reconciliation of queries in order to meet business timelines
Assist with the creation and collection of required study documents both internally and with the investigational study sites
Provide answers to common protocol study related questions under the supervison of the Clinical Director or Associate Trial Manager
Assist in the identification and qualification of study sites
Monitor study sites (site initation visit, intermim monitoring visits and close-out visits) as needed
Assist in execution of laboratory studies and provide support for clinical trials for new products as needed.
Keep current on applicable scientific literature.
Interact with staff from all departments.
Participates in and adhere to the Quality Program as defined by the QSR Adhere to safety SOPs and report potential safety hazards.
Other duties as assigned.
Qualifications
Education/
Experience:
B.A. or B.S. in Biological/Health Sciences
Minimum of 3 years experience as a CRA
Preferred: minimum of one year research and development experience
Skills, Specialized Knowledge and Abilities:
Excellent written and oral communication
Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases
Strong attention to detail
Strong problem solving abilities.
Able to work successfully under tight timelines
Able to manage workload and priorities
Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.
Must possess exceptional communication (written and verbal), interpersonal, problem solving and customer service skills.
Ability to maintain regular attendance and punctuality requirements.
Willing to travel
May be required to work additional hours outside of the normal work shift to ensure business commitments are met (evenings and weekends).
Computer proficiency with Miscrosoft Office projects
Be a self-starter, detail oriented, organized and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast- paced environment.
Highly motivated, readily adapts to changing priorities, effectively manages own time to ensure tasks, multiple projects are completed on time.
Requirements (Physical, Mental, Environmental Demands):
Must be able to concentrate, analyze and solve complex issues throughout the course of the work shift.
Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility.
Must have the ability to lift up to 20 pounds of supplies or finished product throughout the work shift.
Must be able to wear personal protective equipment (latex or nitrile gloves, face shields/safety glasses, etc.).
Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratories
Ability to stand, stoop, reach, push and pull throughout the course of the work shift
Will be required to be fully gowned for performing tasks in a clean room environment
Experiments may involve materials that are considered potentially biohazardous. Must be able to work with human substances such as blood, urine, mucus, stool etc.
Must be able to identify and differentiate color on diagnostic devices or components.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
The Clinical Research Associate assists in the administrative of clinical research projects including development of key study documents, oversite of the clinical trial, and ensuring the quality and integrity of the data according to GCP, ICH and SOPs.
Key Duties
Monitor case report forms and electronic data for quality, completeness, and accuracy
Interact with data management and study sites with generation and reconciliation of queries in order to meet business timelines
Assist with the creation and collection of required study documents both internally and with the investigational study sites
Provide answers to common protocol study related questions under the supervison of the Clinical Director or Associate Trial Manager
Assist in the identification and qualification of study sites
Monitor study sites (site initation visit, intermim monitoring visits and close-out visits) as needed
Assist in execution of laboratory studies and provide support for clinical trials for new products as needed.
Keep current on applicable scientific literature.
Interact with staff from all departments.
Participates in and adhere to the Quality Program as defined by the QSR Adhere to safety SOPs and report potential safety hazards.
Other duties as assigned.
Qualifications
Education/
Experience:
B.A. or B.S. in Biological/Health Sciences
Minimum of 3 years experience as a CRA
Preferred: minimum of one year research and development experience
Skills, Specialized Knowledge and Abilities:
Excellent written and oral communication
Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases
Strong attention to detail
Strong problem solving abilities.
Able to work successfully under tight timelines
Able to manage workload and priorities
Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.
Must possess exceptional communication (written and verbal), interpersonal, problem solving and customer service skills.
Ability to maintain regular attendance and punctuality requirements.
Willing to travel
May be required to work additional hours outside of the normal work shift to ensure business commitments are met (evenings and weekends).
Computer proficiency with Miscrosoft Office projects
Be a self-starter, detail oriented, organized and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast- paced environment.
Highly motivated, readily adapts to changing priorities, effectively manages own time to ensure tasks, multiple projects are completed on time.
Requirements (Physical, Mental, Environmental Demands):
Must be able to concentrate, analyze and solve complex issues throughout the course of the work shift.
Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility.
Must have the ability to lift up to 20 pounds of supplies or finished product throughout the work shift.
Must be able to wear personal protective equipment (latex or nitrile gloves, face shields/safety glasses, etc.).
Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratories
Ability to stand, stoop, reach, push and pull throughout the course of the work shift
Will be required to be fully gowned for performing tasks in a clean room environment
Experiments may involve materials that are considered potentially biohazardous. Must be able to work with human substances such as blood, urine, mucus, stool etc.
Must be able to identify and differentiate color on diagnostic devices or components.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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