Pinnacle Clinical Research·Austin, Texas
Manage day-to-day operations of clinical trials, including participant recruitment, screening, and the execution of study-directed assessments. Ensure strict adherence to study protocols, regulatory requirements, and data confidentiality standards while collaborating with sponsors and vendors.
The Clinical Research Coordinator will manage the day-to-day operations of assigned clinical trials and ensure that pre-established work scope, study protocol, and regulatory requirements are followed. They will recruit and screen study participants, document and report on the daily operations of a study, and report on participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities promptly. This position is responsible for a broad range of duties involving confidential information. Strong communication and organizational skills are essential, along with a proactive, problem-solving mindset.
The Clinical Research Coordinator must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high-quality participant care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, and external vendors, and, therefore, must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team player, and able to manage multiple projects effectively and efficiently. This role reports directly to the Clinical Operations Manager.
Duties: and Responsibilities:
Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Operations Manager, and Site Director or Regional Director
Maintain participant privacy and data confidentiality, complying with the appropriate sponsor requirements and regulations, which include the FDA, ICH GCP, HIPAA, institutional review board determinations, and institutional policies and procedures
Complete study-directed assessments with participants, which may include, but are not limited to, informed consent, medical history, adverse events, Fibroscan, memory screen, test article handling, appointment scheduling, records review, treatment coordination, and collecting vital signs
Complete documentation and data management-related tasks as instructed by supervisor and compliance leadership in accordance with GCP and other regulatory guidelines
Function as a liaison with pharmaceutical sponsors and external vendors, including but not limited to, participating in monitoring visits and audits
Responsible for participant management and engagement from the recruitment of study participants to study completion, as applicable.
Respond to internal and external requests for information promptly
Identify opportunities to improve participant care and satisfaction
With a solutions-oriented and collaborative mindset, resolve study-related challenges within a reasonable time set by the supervisor
Establish, develop, and maintain productive relationships with internal and external personnel to achieve a high standard of research outcomes.
Coordinate multiple projects with competing priorities and deadlines as needed, based on clinical trial protocol directives and study volume
Attends the investigator’s meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by monitors or sponsor representatives as appropriate
Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status is kept current
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Supervisory Responsibilities: None
Certificates and Licenses: Valid Driver’s License
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work is performed in an office/laboratory and/or a clinical environment.
Exposure to biological fluids and/or bloodborne pathogens.
Personal protective equipment is required, such as protective eyewear, garments, and gloves.
Occasional travel may be required, domestic and/or international.
Ability to work in an upright and/or stationary position for 6-10 hours per day.
Frequent mobility required.
Occasional squatting, kneeling, or bending.
Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.
Summit Clinical Research Solutions is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status, or any other protected Federal, State/Province, or Local status unrelated to the performance of the work involved.
Requires a high school diploma (Bachelor's preferred) and 1-2 years of experience in clinical research. Must be proficient in ICH/GCP guidelines, CRIO or equivalent CTMS, and possess strong organizational and communication skills.
Market context
Clinical Research Coordinator positions in Texas are often competitive because employers look for candidates who can manage protocols, documentation, and participant communication while working within ICH/GCP standards. This role typically favors applicants with clinical research experience, strong organization, and clear communication, and benefits like medical, dental, vision, life insurance, and paid time off can make offers more attractive. Review the AI-summarized requirements and benefits here to save time, then tailor your application to highlight GCP knowledge and hands-on research coordination experience.
Clinical Research Assistant
Clinical Research Coordinator
Clinical Research Assistant