Clinical Research Associate/Study Coordinator

Position Title: Clinical Research Associate / Study Coordinator

Reports to: Regional VP of Operations

Job Status: Full-Time/Part time

FLSA Status: Non-Exempt

Positions Supervised: None

Position Summary:

The Clinical Research Associate / Study Coordinator will oversee and manage clinical research studies within the urology department. This role involves coordinating all aspects of clinical trials, ensuring compliance with regulatory requirements, and supporting patient recruitment and data collection efforts.

Duties and Responsibilities:

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.

· Coordinate and manage urology and oncology-related clinical trials from initiation to close-out.

· Screen, recruit, and enroll study participants in accordance with protocol guidelines.

· Obtain informed consent and educate participants about study procedures.

· Maintain accurate and complete study documentation including source documents, case report forms, and regulatory binders.

· Monitor patient safety and report adverse events or protocol deviations.

· Collaborate with principal investigators, sponsors, and regulatory bodies.

· Prepare and submit IRB documents and ensure ongoing compliance.

· Collect, enter, and manage clinical data using electronic data capture systems.

· Schedule and track study visits, procedures, and follow-ups.

· Assist in grant applications, manuscript preparation, and presentations.

· Perform other duties as assigned

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

· Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.

· Dependability - Follows instructions, responds to management direction; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

· Communication - Effectively communicates procedures and instructions to patients and healthcare team. Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Able to read and interpret written information.

· Adaptability - Adapts to changes in the work environment; Manages competing demands; Change’s approach or method to best fit the situation.

· Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Follows through on commitments.

· Analytical problem solving-Analyzes complex problems by gathering relevant data, identifying route causes, and developing logical effective solutions.

Education and Experience:

· Bachelor’s degree in a health-related field (e.g., Nursing, Biology, Public Health).

· 3-5 years of experience in clinical research, preferably in urology, oncology or a related specialty.

· Knowledge of FDA regulations, ICH-GCP guidelines, and HIPAA compliance.

· Strong organizational and communication skills.

· Proficiency in Microsoft Office and clinical trial management systems.

· Certification in clinical research (e.g., ACRP or SOCRA) preferred.

· Experience with multicenter trials and industry-sponsored studies.

· Familiarity with urologic conditions and procedures.

· Ability to work independently and manage multiple studies simultaneously.

Work Environment:

· Moderate noise level typical of a busy clinic.

· Clean, well-lit, and ventilated

· Potential exposure to communicable diseases and radiation

· May share space with other coordinators or research staff.

Physical Demands:

· Standing/walking for extended periods (4–6 hours/day)

· Lifting/carrying equipment or assisting patients (up to 50+ lbs)

· Exposure to stress due to safety, accuracy, and patient care demands

Job Type: Full-time

Pay: From $31.25 per hour

Expected hours: No more than 40 per week

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Clinical research: 3 years (Required)
• Urology: 1 year (Preferred)
• Oncology: 1 year (Preferred)

License/Certification:

• ACRP/SOCRA (Preferred)

Work Location: In person