Clinical Research Coordinator II - OBG - Research Staff

About the role

The job compiles, documents, analyzes, and reports on moderately complex clinical studies. It provides input to support administrative and operational decisions impacting clinical research conducted across the University. The Clinical Research Coordinator II independently manages and executes moderately complex clinical research studies from start-up through close-out. This role serves as a central operational lead, ensuring scientific integrity, regulatory compliance, and seamless coordination across investigators, sponsors, and multidisciplinary teams.

Responsibilities

• Develop study protocols, CRFs, and other study documents.
• Work closely with Principal Investigators (PIs) and laboratory team members.
• Operate, troubleshoot, and maintain specialized laboratory machinery.
• Sample preparation, including collecting, labeling, and processing biological samples for testing.
• Set up experiments, run protocols (e.g., cell culturing, DNA extraction, PCR, ELISA, and staining slides and microscopy).
• Assist with animal care and study design.
• Data management, collecting, recording, and analyzing data, often using computerized equipment.
• Keep detailed documentation of lab notebooks that document every step of an experiment.
• Manage lab maintenance, clean equipment, manage inventory, and handle hazardous materials.
• Develop instructional regulatory body (IRB) protocols, amendments, and other documents as well as respond to IRB stipulations and requirements.
• Collect, archive subjects' data.
• Aid in scientific data dissemination.
• Develop, write, edit, submit, and publish scientific manuscripts and present scientific abstracts at national and international conferences.
• Participate in local and national meetings related to multi-center trials and participate in regular phone/skype meetings related to clinical research.
• Submit regular progress reports to NIH and other sponsors of clinical research studies.
• Provide technical and administrative support in a laboratory environment performing basic laboratory techniques, research, and analysis under direction.
• Comply with institution, state, and federal regulatory policies, procedures, directives, and mandates.
• Analyze, facilitate, and participate in the daily activities of multiple moderately complex clinical trials and perform all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, subject consenting, subject recruitment, performing and supervising various study visit procedures, and participating in program audits.
• Prepare program conference lists for multidisciplinary conferences and workshops.
• Participate in all pharmaceutical site visits.
• Use moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
• Solve a range of straightforward problems relating to the administration of the compliance, financial, and other related aspects of a clinical study.
• Interpret the data needed for insurance submissions.
• Gather pre-testing results if obtained at an outside facility.
• Accountable for all tasks in moderately complex clinical studies.
• Facilitate and participate in the daily activities of moderately complex clinical studies and perform various activities including patient data retrieval, documenting clinical research records, and participating in program audits.
• Perform other related work as needed.

Requirements

Education: Minimum Qualifications Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline. Certifications: Preferred Qualifications Education: College or university degree in related field. Advanced degree in research or a related field strongly preferred. Experience: 2-5 years of work experience in a related job discipline. Previous clinical trials experience. Previous IRB protocol experience.

Preferred Competencies

• Ability to independently coordinate and manage moderately complex clinical research studies from start-up through close-out.
• Knowledge of IRB processes, regulatory requirements, and institutional, state, and federal research policies.
• Strong data management and analytical skills, including experience with REDCap, Excel, and other research data systems.
• Understanding of research methodologies and basic laboratory techniques applicable to clinical and non-clinical studies.
• Sound problem-solving skills with the ability to exercise professional judgment in resolving study-related operational, compliance, and financial issues.
• Effective collaboration and communication skills when working with investigators, sponsors, multidisciplinary teams, and external partners.
• Strong organizational skills and attention to detail with the ability to manage multiple studies and competing priorities.