Clinical Research Associate II
Designs, plans and implements the overall direction of clinical research projects. Evaluates and analyses clinical data. Must have knowledge in reference to good clinical practices regulations and standard operating procedures. Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms. Conducts clinical monitoring of field sites to supervise and coordinate clinical studies. May write protocols. May require travel to field sites.
- Participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and external parties to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
- Travels to field sites to monitor studies.
- Receives general instructions; plans and prepares studies.
- Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
- Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
- Collects and maintains legal and regulatory documentation, as applicable.
- Assumes responsibility for training and coordinating certification of study site personnel.
- Ensures accurate and complete study management/data collection and transfer to data management
- Ensures site compliance with regulations and study protocol.
- Monitors the sites and provides technical assistance, as necessary.
- Assists, prepares and manages study timelines
- Manages material logistics for the studies.
- Conducts reference material testing in-house.
- Organizes investigator meetings, as necessary.
- Participates in Project Team Meetings.
- Keeps informed of trends and developments in clinical research.
- Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity.
- Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions.
- Bachelor degree in scientific discipline or related field required, or equivalent combination of education and work experience.
- 2+ years of experience in clinical study coordination, clinical site monitoring or clinical study management is required, 5+ preferred.
- Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) is preferred.
- A background in biomedical/healthcare services with laboratory experience preferred.
Knowledge, Skills, and Abilities:
- Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
- Excellent writing and verbal communication skills.
- Well organized and detail oriented.
- Impeccable record keeping and filing skills.
- Excellent time management skills.
- Ability to give presentations and teach others.
- Ability to work effectively in a team, and also work independently on assigned tasks
- Travel Requirement: Approximately 30% of time travel domestic and/or international.