The Clinical Research Associate (CRA) is responsible to organize and oversee clinical data collection 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 the Minneapolis office and reports to the Clinical Trial Manager.
- Supervise study sites to ensure adherence to the protocol and all regulatory requirements and appropriate company and industry standards
- Create, collect and authenticate 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
- Ensure proper transmission of clinical data to data management persons
- 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
- Organize clinical data on individual cases into short summaries
- Perform desk research to prepare background information for publications and scientific abstracts
- Monitor and collect clinical information discussed or shared with clinical affairs
- Participate in clinical trials by reviewing data and supporting data collection
- 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 as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
- Perform other duties as assigned by management
- May work cross functionally with Marketing and Sales teams to prepare and review abstracts and scientific publications.
- May screen potential study participants through medical record reviews, interviews and follow-ups with healthcare providers
- Write reports to document the clinical data associated with a new product.
- Assist with training, mentoring and development of new employees.
- Assist Clinical Project Manager and VP of Clinical Affairs by managing project budgets
- Oversee research, technical and administrative staff, potentially to include training, goal setting and distribution of workload
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
Travel, including air travel, 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.