The CRC/Operations Lead is a senior team member responsible for conducting clinical trials while also serving as a go-to resource for operational questions, training, and workflow support. In addition to managing their own study protocols, this individual provides guidance to staff on all site study protocols, site policies, and documentation practices. The CRC/Operations Lead supports training and onboarding, helps troubleshoot day-to-day challenges, and assists with administrative oversight, including timecard reviews. The distribution of work will be CRC/coordinating trials 75% and research operations lead duties 25%.
KEY RESPONSIBILITIES:- Manage assigned clinical trials end-to-end, including participant visits, data collection, source documentation, and sponsor relations.
- Able to manage multiple studies with varying indications.
- Leads complex trials, ensuring compliance with protocol and regulatory requirements.
- Develops effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials.
- Demonstrations understanding of Urology America and key stake holders to ensure continuing of patient care.
- Work to build the research department in scope, size, reputation, and professionalism.
- Serve as a study resource for CRCs and support personnel.
- Provide day-to-day operational support, helping staff interpret study protocols, procedures, and SOPs.
- Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
- Attend all site SIVs and other sponsor meetings to ensure smooth study start-up and expedited enrollment.
- Support study feasibility activities alongside Investigators and site managers.
- Train and mentor new and existing CRCs, including shadowing, skills checks, and protocol-specific training.
- Ensures good Investigator relations and manages trainings, schedules, and other communications/processes needed for Investigator support.
- Assist in creating and updating training materials and onboarding workflows.
- Support the Clinical Research Manager with administrative oversight, such as reviewing timecards, study/office supply needs, or visit scheduling concerns.
- Attend site selection visits and support business development of the site.
- Support study feasibility activities alongside Investigators and Site Managers.
- Attend site selection visits and support business development of the site.
- Train and mentor new and existing CRCs, including shadowing, skills checks, and protocol-specific training.
- Ensures good Investigator relations and manages training's, schedules, and other communications/processes needed for Investigator support.
- Assist in creating and updating training materials and onboarding workflows.
- Support the Clinical Research Manager with administrative oversight, such as reviewing timecards, study/office supply needs, or visit scheduling concerns.
- Participate in site audits or monitoring visits, helping staff with compliance preparation.
- Help CRCs with reviewing monitoring visit follow-up letters to ensure the action items are completed in a timely manner.
- Oversight on binder management.
- Act as a liaison between individual market operations and leadership, elevating staffing, policy, or workflow concerns as needed.
- Ensure study conduct is compliant with GCP, IRB, SOPs, and ALCOA-C documentation standards.
- Act as the point person to the local market clinic and leadership teams.
- Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records.
- Support vendor management and vendor set up.
- Ensures CTMS compliance and completion.
- Partner with finance to ensure local site CTMS completion and proper invoicing.
PERFORMANCE REQUIREMENTS:Knowledge- Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.
- Understanding of medical terminology.
Skills- Ability to use multi-line phone systems and basic computer systems.
- Interpersonal communication with internal staff and external customers.
- Skill in evaluating and implementing study protocols and budgets.
- Skill in reading medical chart terminology.
- Time Management.
Abilities- Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
- Elicit appropriate information for patients to clinic staff.
- Ability to read and understand information and ideas presented in writing.
- Ability to apply general rules to specific problems to produce answers that make sense - deductive reasoning.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be provided to enable individuals with disabilities to perform the essential functions:
- Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up-to 20 pounds.
- Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.
QUALIFICATIONS:- 5+ years of experience as a Clinical Research Coordinator.
- 2+ years of supervisor or team lead experience preferred.
- Proven knowledge of GCP, FDA regulations, and site-level clinical research operations.
- Strong leadership, mentorship, and interpersonal communication skills.
- Experience training or mentoring others preferred.
- Detail-oriented and able to manage multiple responsibilities with minimal supervision.
- Urology therapeutic area experience preferred.
ERFORMANCE REQUIREMENTS:Knowledge- Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.
- Understanding of medical terminology.
Skills- Ability to use multi-line phone systems and basic computer systems.
- Interpersonal communication with internal staff and external customers.
- Skill in evaluating and implementing study protocols and budgets.
- Skill in reading medical chart terminology.
- Time Management.
Abilities- Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
- Elicit appropriate information for patients to clinic staff.
- Ability to read and understand information and ideas presented in writing.
- Ability to apply general rules to specific problems to produce answers that make sense - deductive reasoning.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:
- Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.
- Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.
QUALIFICATIONS:- 2-5 years of experience as a Clinical Research Coordinator.
- Proven knowledge of GCP, FDA regulations, and site-level clinical research operations.
- Strong leadership, mentorship, and interpersonal communication skills.
- Experience training or mentoring others preferred.
- Detail-oriented and able to manage multiple responsibilities with minimal supervision.
- Urology therapeutic area experienced preferred.
