Sr. Clinical Research Coordinator (32576) in Alexandria, Virginia at GI Alliance

Description

In the performance of their respective tasks and duties all employees are expected to conform to the following:

• Perform quality work within deadlines with or without direct supervision.

• Interact professionally with other employees, customers and suppliers.

• Work effectively as a team contributor on all assignments.

• Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.

Position purpose

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Site Manager and Principal Investigator (PI). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Responsibilities/Duties/Functions/Tasks:

• Acts as a point of reference for study participants by answering questions and keeping them informed of study progress.

• Maintains ongoing communication with sponsors, research participants, Site Manager, and PI throughout the course of the study.

• Manage the day-to-day activities of the study including problem solving, communication and protocol management.

• Support the Clinical Research Manager with administrative oversight, such as reviewing timecards, study/office supply needs, or visit scheduling concerns.

• Provide day-to-day operational support, helping staff interpret study protocols, procedures, and SOPs.

• Ensure all safety data is reviewed by the PI in a timely manner.

• 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.

• Work to build the research department in scope, size, reputation, and professionalism.

• Serve as a study resource for CRCs and support personnel.

• 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 manager.

• Participate in site audits or monitoring visits, helping staff with compliance preparation.

• Train and mentor new and existing CRCs, including shadowing, skills checks, and protocol-specific training.

• Assist in creating and updating training materials and onboarding workflows.

• Ensures good Investigator relations and manages training, schedules, and other communications/processes needed for Investigator support.

• 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.

• Support vendor management and vendor set up.

• Ensures CTMS compliance and completion.

• Partner with finance to ensure local site CTMS completion and proper invoicing.

• Other duties as assigned.

Qualifications

Qualifications

Education: Bachelor’s Degree preferred

Experience: Minimum 5 or more years of clinical research coordinating experience. Experience in phlebotomy preferred. Experience in Urology is preferred.

Other Requirements: None

Performance Requirements:

• Knowledge of grammar, spelling, and punctuation.

• Knowledge of purchasing, budgeting, and inventory control.

• Skill in taking and transcribing dictation and operating office equipment.

• Skill in answering the phone and responding to questions.

• Skill in time management, prioritization, and multitasking.

• Skill in writing and communicating effectively.

• Skill in evaluating and implementing study protocols and budgets.

• Skill in reading medical chart terminology.

• Ability to work under pressure, communicate and present information.

• Ability to read, interpret, and apply clinical policies and procedures.

• Ability to identify problems, recommend solutions, organize and analyze information.

• Ability to multi-task, establish priorities, and coordinate work activities. Time management.

• Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.

• 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.

• 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.

• Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

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. Stress can be triggered by multiple staff demands and deadlines