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Clinical Research Coordinator
3 months ago
MUST HAVES:
- Must be able to go on-site 5 days a week in Austin, TX
- Must have Prior CRC experience
- Must have experience in CNS and/or Podiatry Therapeutic areas
Description:
Clinical Research Coordinator opening in Austin, Texas.
The CRC will coordinate the execution of all clinical study protocol activities while maintaining Good Clinical Practice (GCP) and adhering to the Food and Drug Administration (FDA) regulations.
The CRC's main responsibility is the conduct of multiple clinical trials, working closely with the Principal Investigator, Sub-Investigators, and support staff.
- Interprets protocol(s) correctly and completely to ensure consistent compliance with applicable standards and related requirements.
- Educates patients and healthcare professionals on the study protocol to ensure complete and correct understanding of information.
- Reviews medical records against inclusion/exclusion criteria to identify potential subjects.
- Presents information and responds to questions in accordance with standards of professional practice and compliance requirements in relation to matters including, but not limited to, obtaining informed consent.
- Maintains and prepares lab kits for subject visits.
- Coordinates subject visit with Investigator Team.
- Maintains clinical source records.
- Organizes Investigator Site Files.
- Ensures call notes and documentation is accurate.
- Complies with all regulatory requirements, guidelines, and local regulations.
- Prepares IRB submissions to include but not limited to development of ICF and any supporting documentation required for submission.
- Prepares Regulatory documents per sponsor requirements (FDA Form 1572, Financial Disclosure forms, etc.).
- Coordinates and maintains the following logs: Delegation of Authority, Deviation Logs, Enrollment, Study Status Logs.
- Coordinates Site Training.
- Transcribes source to EDC platforms.
- Hosts Sponsor and Monitor Visits.
- Demonstrates integrity, teamwork, respect, and accountability in all aspects of the job.
- Performs job duties and assigned tasks in a safe, efficient, and effective manner, as well as in a manner that is compliant with all company policies, procedures, protocols, and practices.
- Perform other duties assigned as it relates to the business needs
Minimal Education & Experience Requirements:
High school diploma or equivalent GED
Two to Four years of experience working in a CRC role; or
An equivalent combination of education and experience
Knowledge of protocol and medical terminology
Knowledge of regulatory requirements and HIPAA requirements
Strong team player with interpersonal skills
Must be able to work in a high pace environment
Exceptional organizational and time management skills, ability to prioritize task - Detailed oriented
Computer Skills (familiar with electronic health record systems, Microsoft Office
CCRC Certification preferred, GCP and IATA
Physical Requirements & Working Environment:
This position requires frequent sitting, walking, standing, reading, seeing, speaking, hearing, listening, organizing, interpreting data and information, operating office equipment, typing using a computer keyboard, and viewing a computer screen monitor.
The working environment consists of an indoor and climate-controlled setting the majority of the time, and with frequent exposure to a healthcare clinical setting to include, without limitation, frequent potential exposure to blood borne pathogens, and other possible hazards within a clinical setting.
About ActalentActalent is a global leader in engineering and sciences services and talent solutions.
We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.
With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people.
DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.
