Job Description

Job Description

Job Description

Description:

Summary

The Clinical Research Associate (CRA) is responsible to organize and oversee clinical sites contributing to advances in the medical community. A competent Clinical Research Associate should be able to perform various duties and responsibilities. Proper fulfillment of a Clinical Research Associate’s duties and responsibilities brings success to your company. Clinical Research Associates should assist in organizing and monitoring the different stages of clinical research development.

The Clinical Research Associate is located in a Kerecis office or remote home office with regular travel to clinical sites and reports to the Senior Director of Clinical Affairs.

Essential Functions

• Supervise study sites to ensure adherence to the protocol and all regulatory requirements and appropriate company and industry standards
• Create, collect and source data verify data collection forms
• Coordinate with ethics committees to safeguard rights, safety and wellbeing of all research subjects and research activities
• Maintain specific records of research activity to include regulatory forms, investigational product dispensation records, case report forms and consent forms
• Support development of final reports, manuscripts or publications as well as the clinical sections of clinical, regulatory and quality documents
• Review case report questions and problems and clarify or obtain alterations to data as appropriate
• Query clinical data issues and oversee the resolution of all queries.
• .
• Monitor and collect clinical information discussed or shared with clinical affairs.
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
• Support data analysis projects through data entry, data cleaning, data validation and data analysis.
• Coordinate designated clinical projects
• Assist with training, mentoring and development of new employees.
• Assist Director of Clinical Affairs by managing project budgets, submission of invoices, etc.
• Perform other duties as assigned by management

Requirements:

Competencies

The CRA must be highly dependable and self-motivated. The CRA must also be resourceful and efficient when taking on tasks, have the ability to problem-solve and pay exceptional attention to detail. The CRA must have strong organizational and communication skills in addition to the ability to deliver a high level of customer service. This position’s primary goal is to perform data collection and desk research needed to support the Clinical Research team.

• Must be proficient with scientific software
• Strong written and oral communication skills
• Ability to build effective relationships with trial center colleagues and staff
• Superior problem solving, deductive reasoning and decision-making skills
• Good time management and ability to prioritize tasks and accomplish set goals efficiently
• Knowledge of statistical data collection, validation, editing and analysis techniques
• Ability to provide technical guidance, advice and support to professional staff where needed
• Knowledge of laboratory certification processes and standards
• Excellent attention to detail and ability to maintain detailed and accurate records

Education & Experience

• Sufficient knowledge and training to excel at the job
• PREFER graduate or a postgraduate degree in medical sciences like immunology, anatomy, physiology and medicine.
• Bachelor’s degree in life sciences such as biochemistry, biology, microbiology and pharmacology required
• CCRA certification preferred

Travel - Regular travel, including air travel, up to 50% of the time may be required and is an essential function of the role.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.

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