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
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
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.
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Medical Equipment Manufacturing
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