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About the Role

The Senior CRC will coordinate daily operations of clinical research studies, oversee clinical research staff, and ensure compliance with human research subject regulations.

Responsibilities

• Assist with mentoring and training clinical research staff.
• Perform clinical functions such as phlebotomy and monitoring vital signs.
• Educate family and contribute to the care and evaluation of subjects.
• Determine preliminary inclusion/exclusion criteria.
• Liaise with agencies, pharmaceutical companies, laboratories, vendors, and supply companies.
• Oversee availability of supplies and equipment for studies.
• Manage multiple concurrent trials, including screening, recruiting, and enrollment.
• Perform patient/research participant scheduling.
• Coordinate protocol-related research procedures, study visits, and follow-up.
• Collect patient/research participant history.
• Collect and maintain source documentation.
• Perform data entry and query resolution.
• Prepare IRB submissions, update modifications, continuing reviews, and reportable events.
• Develop strong working relationships and maintain effective communication with study team members.
• Complete all protocol-related training and adhere to IRB approved protocols.
• Support the collection and review of required essential study documents and reports.
• Order supportive study supplies.
• Assist in the informed consent process of research subjects.
• Support and advocate for the safety of research subjects.
• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities.
• Collect, process, and ship laboratory specimens.
• Comply with Innovo, Clinic, and Sponsor policies, SOPs, and applicable regulatory requirements.
• Perform all additional duties as assigned.

Requirements

• At least 3-5 years of experience coordinating clinical trials.
• BS/BA in Life Science or related discipline.
• Previous GCP training and certification required.
• Working knowledge of current ICH GCP guidelines and applicable regulations.
• Experience in a clinical setting.
• Demonstrated ability in positive relationship building.
• Previous experience with training and mentoring other clinical research professionals is a plus.
• Strong interpersonal skills with attention to detail.
• Positive attitude and ability to interact with all levels of staff.
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint).
• Demonstrated proficiency with clinical trial master filing systems.
• Strong organization/prioritization skills for managing multiple concurrent projects.
• Understanding of Regulatory and Central/Local ethic submission processes.
• Ability to manage multiple competing priorities within various clinical trials.
• Excellent verbal and written communication skills.
• Ability to work independently, prioritize, and work with a matrix team environment.
• Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.
• Applicants must be authorized to work for ANY employer in the U.S.
• Unable to sponsor or take over sponsorship of an employment Visa.

Skills

• Phlebotomy
• Monitoring vital signs
• MS Office skills (Outlook, Word, Excel, PowerPoint, SharePoint)
• Clinical trial master filing systems
• Regulatory and Central/Local ethic submission processes

Location

• Austin, TX 78735

Work Type

• Full Time
• Onsite

Experience Level

• Senior

Education Level

• BS/BA in Life Science or related discipline
• Certified Clinical Research Coordinator (CCRC) certification preferred

Salary/Compensations

• $59,481.20 - $81,786.65 Salary/year

Benefits

• Competitive salary
• Health Insurance
• Dental Insurance
• Disability Insurance
• Life Insurance
• Paid Time Off
• Vision Insurance

About the Company

• Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.

Equal Opportunity

• All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
• Innovo Research will not tolerate discrimination or harassment based on any of these characteristics.
• In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.