Clinical Research Associate I or Clinical Research Associate II
About The Position
The CRA I or CRA II will operate under general supervision. Performs activities consistent with those of a Study Coordinator role such as maintenance of protocol portfolio(s), informed consent(s), and preparation/submission of complex study documents. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data to the collaborating research organization or study sponsor. Prepares complex data reports. Serves as a mentor and preceptor to staff. CRA II Job Responsibilities: Acts as site Study Coordinator by maintaining essential study documents (Investigator File) for assigned protocols, conducting informed consent process as designated by principal investigator (PI), and assisting PI with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g. CTSRC and IRB) as applicable. Serves as preceptor/mentor to new clinical research staff. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events (e.g., adverse events, protocol variances, violations, etc.). Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data to the collaborating research organization (CRO) or study sponsor. Prepares detailed and high complexity data reports. Maintains appropriate professional competencies; completes appropriate training on the protection of human subjects during the first 6 months of employment. Performs other related duties as directed to meet the goals and objectives of the department and the institution.
Requirements
- Bachelor’s degree in a related biomedical/bio-behavioral field required
- Master’s degree preferred
- Two (2) years of direct experience in clinical biomedical and/or behavioral research required
- Certification in clinical research from the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP) must be obtained within three (3) years of assuming the position
- Bachelor's degree in relevant area required
- Prior industry experience preferred
- Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes
- Adapts quickly to changing priorities to perform as needed in his/her role
- Remains calm when faced with changes to (and in) his/her work
- Seeks clarifications to understand what is being said
- Is able to clearly summarize information learnt to confirm understanding
- Writes in a clear and concise manner and speaks succinctly and confidently
- Plans in advance, organizes own work, and executes high-quality work on time
- Shows initiative to take on more responsibilities/work
- Embraces goals and demonstrates a sense of urgency in achieving them
- Holds self to high standards and keeps pushing to meet them
- Supports clinical study and site management by performing basic tasks (operations/study management) under supervision
- Exhibits understanding of key concepts related to clinical studies (e.g., baseline determinants of new study selection process, risk assessments)
Nice To Haves
- Master’s degree preferred
Responsibilities
- Acts as site Study Coordinator by maintaining essential study documents (Investigator File) for assigned protocols
- Conducting informed consent process as designated by principal investigator (PI)
- Assisting PI with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g. CTSRC and IRB) as applicable
- Serves as preceptor/mentor to new clinical research staff
- Performs data abstraction, collection, and entry to support clinical research
- Prepares submission for all reportable events (e.g., adverse events, protocol variances, violations, etc.)
- Develops, maintains, and/or monitors case report forms
- Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s)
- Provides data to the collaborating research organization (CRO) or study sponsor
- Prepares detailed and high complexity data reports
- Maintains appropriate professional competencies
- Completes appropriate training on the protection of human subjects during the first 6 months of employment
- Performs other related duties as directed to meet the goals and objectives of the department and the institution
Benefits
- Explore our exceptional benefits !
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
