San Francisco Bay Area, CA
Clinical Research Associate II
The Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up, activation, maintenance and closure of global clinical trials while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives. In collaboration with the Clinical Research Manager, the CRA II maintains consistent CRF data quality and discrepancy interpretation across sites. The CRA II will develop a basic understanding of the disease and indication.
Essential Job Functions
- May participate in study design and study set up activities.
- May conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol. compliance, accurate and thorough data collection, and appropriate study conduct.
- Prepares monitoring reports per SOPs.
- Participates in the review of monitoring visit reports for completeness.
- Supports development of study training and may provide study site training to site personnel.
- Provides study training to internal employees as applicable.
- Assists in development of CRF design, CRF guidelines and supports database development when applicable.
- Develops study tools and guidelines to be utilized by study sites.
- Develops basic knowledge of the process used to evaluate and select potential investigators and sites.
- Develops basic knowledge of the process used to evaluate and select potential vendors as applicable.
- Interacts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues.
- Independently reviews CRFs and resolves data management and data query issues with study coordinators and investigators.
- Performs manual in-house review of CRF data in clinical database for completeness, accuracy and performs data trending as needed.
- Analyzes and evaluates clinical data gathered during research.
- Drafts informed consents as applicable.
- Reviews site’s informed consent forms against the consent template for presence of all GCP. requirements and protocol specific information and revises as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand.
- Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy.
- Ensures study records are auditable both at investigational sites and in-house.
- Responsible for tracking Safety Reports for assigned sites.
- Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports.
- Initiates device shipments to ensure that study supplies are adequate for assigned studies and accurately accounted throughout study.
- Develops basic knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies.
- May be responsible for initiating and tracking quarterly site payments and reconciling study invoices.
- Communicates status of trial to manager and team.
- May be responsible for development or revision of SOPs or work instructions.
- Appropriately represents functional area.
- Bachelor’s degree in science or healthcare with a minimum of 2 years of medical device. industry experience directly supporting clinical research in a Sponsor role.
- Must have excellent verbal and written communication skills.
- High attention to detail and organizational skills are necessary.
- Basic understanding of peripheral and coronary artery disease and therapies preferred.
- Working knowledge of GCP, FDA, ISO and other applicable regulations.
- Ability to travel 10-20% domestically and internationally.
- Experience with EDC Data Management Systems.
- Ability to work in a fast-paced environment while managing multiple priorities.
- ACRP or SOCRA clinical research certification preferred.
- Operate as a team and/or independently while demonstrating flexibility to changing requirements.