Clinical Research Associate
1 week ago
**DESCRIPTION**
The Clinical Research Associate (CRA) - Site Manager will coordinate clinical studies and be responsible for all major stages of study development, execution, monitoring, and close-out.
**RESPONSIBILITIES**:
- Drafts materials including informed consents, case report forms (CRFs), CRF completion guidelines, and technical instructions.
- Carries out clinical site qualification, contract negotiation, IRB/ethical committee submissions, protocol initiation, site monitoring, and site close-out
- Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
- Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
- Conducts clinical site and data monitoring and completes monitoring visit reports
- Supports study supply, biospecimen delivery, and biospecimen testing logistics
- Evaluates clinical data and coordinates data query resolutions
- Supports internal departmental quality compliance
- Prepares progress reports and performance metrics
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Independently administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to CTL and/or line manager.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- Required travel to investigative sites up to 10%
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**:
- Clinical Research Competencies:
- Clinical site management and monitoring experience
- Advanced knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Strong written and verbal communication skills including good command of English language
- Excellent organizational and problem-solving skills
- Effective time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
Degree or currently enrolled in bachelor's degree program in health care or other related discipline.; or equivalent combination of education, training and experience
**PHYSICAL REQUIREMENTS**:
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Frequent travel to sites, primarily domestic, may include international travel
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