Job Overview:
The Clinical Research Associate II monitors investigational sites to ensure subject safety and provides high quality data review and reporting in compliance with the Company and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations. Builds, manages and supports site relationships while serving as liaison between the Sponsor and assigned sites.
Job Duties and Responsibilities:
- Provides support to Project Team and Clinical Operations Team.
- Maintains working knowledge of protocols and Monitoring Plans for assigned projects.
- Demonstrates strong written and verbal communication skills.
- Serves as primary contact for assigned research sites.
- Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
- Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
- Ensures assigned sites are conducting studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
- Verifies that the rights and well-being of trial subjects are protected.
- Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
- Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
- May support translations of essential documents
- May support submission of trials to IRB/IEC and regulatory authorities.
- Verifies that written informed consent was obtained before each subject’s participation in the trial.
- Verifies that the investigator is enrolling only eligible subjects.
- Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.
- Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
- Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
- Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
- Ensures that sites have sufficient project specific supplies.
- Manages investigative sites in respect to the trial conduct and motivates sites to meet study goals.
- Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
- Delivers quality written trip reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans.
- Attends and participates in team teleconferences and training.
- Participates in relevant trial meetings, e.g. Kick off, Investigator, and Monitor meetings.
- Participates in site audits, as requested.
- May conduct site and study feasibility assessments.
- May be involved in the development of monitoring guideline and tools.
- Provides input into study documentation and monitoring worksheets.
- Uphold the confidentiality agreements with all clients and colleagues outside Company.
- Pays attention to signals of fraud, misconduct and escalates per Company SOP.
- Work according to the Company Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.
- Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the Company time allocation system.
- Demonstrates flexibility and adaptability.
- Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
- Other duties as assigned by Clinical Operations Manager/Project Manager and per project-specific requirements.
May participate in delivering Clinical Monitoring portion of a bid defense presentation.
Job Requirements:
- Education
- 4 year college graduate, preferably with a healthcare or life science degree.
In lieu of a degree, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
- Experience
Minimum of 1 year of experience in on- site monitoring clinical studies.
- Skills/Competencies
- Strong written and verbal communication skills
- Strong interpersonal skills
- Strong monitoring skills to independently conduct all types of site monitoring visits
- Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding) Proficient computer skills, including Microsoft Office
- Comprehensive knowledge of GCP/ICH guidelines
- Proficiency in medical terminology
- Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
- Attention to detail
- Problem-solving skills
- Ability to work in a matrix environment
Strong time management and organizational skills
- Capabilities
- Ability to drive an automobile and have a valid driver’s license, if applicable.
- Valid passport required in the case of international business travel.
- Ability to travel up to 80%.