Clinical Research Coordinator

Overview

The Clinical Research Coordinator oversees research studies, ensuring compliance with protocols, regulatory guidelines, and ethical standards. Key responsibilities include managing data accuracy, regulatory submissions, and participant recruitment, as well as coordinating Research Oversight Committee (ROC) meetings and communications among stakeholders.

This role provides leadership to research staff, ensuring adherence to best practices and data integrity. The coordinator also develops and monitors project budgets, assists with grant applications, and ensures financial and regulatory compliance. Close collaboration with IRBs and regulatory bodies is essential to uphold ethical and regulatory standards throughout all research activities.

Responsibilities

Study Management and Compliance

Oversees the execution of research studies, ensuring adherence to protocols, regulatory guidelines, and ethical standards. Manages data accuracy, regulatory submissions (IRB, federal regulations, HIPAA), and adverse event reporting. Prepares research sites for audits and ensures compliance with data integrity standards.

Ethical and Regulatory Integrity

Coordinates with IRBs and regulatory bodies to ensure timely submission of required documentation. Upholds ethical guidelines in participant recruitment, consent, and data management. Monitors compliance with approved protocols and recommends corrective actions as needed.

Oversight and Communication

Organizes and coordinates Research Oversight Committee (ROC) meetings, preparing agendas and materials, and ensuring timely communication between committee members, researchers, and stakeholders. Manages meeting documentation, follow-ups, and research requests, including protocol reviews and amendments.

Participant and Stakeholder Engagement

Manages participant screening, recruitment, and enrollment while ensuring ethical standards are upheld. Collaborates with investigators, physicians, and other professionals to facilitate research and protect participant rights.

Operational and Financial Oversight

Develops and monitors research project budgets, ensuring responsible financial management and reporting. Assists with grant applications and funding compliance while identifying cost-saving opportunities without compromising research quality. Implements technology solutions and mitigates project risks.

Team Leadership and Staff Management

Supervises, trains, and develops research staff. Ensures quality control and integrity of research data through continuous performance evaluation and adherence to best practices.

DCH Standards:

• Maintains performance, patient and employee satisfaction and financial standards as outlined in the performance evaluation.
• Performs compliance requirements as outlined in the Employee Handbook
• Must adhere to the DCH Behavioral Standards including creating positive relationships with patients/families, coworkers, colleagues and with self.

• Performs essential job functions in a manner that ensures the safety of patients, visitors and employees.
• Identifies and reduces unsafe practices that may result in harm to patients, visitors and employees.
• Recognizes and takes appropriate action to reduce risks and hazards to promote safety for patients, visitors and employees.

• Requires use of electronic mail, time and attendance software, learning management software and intranet.
• Must adhere to all DCH Health System policies and procedures.
• All other duties as assigned.

Qualifications

Licensure and Education
Minimum Required: Registered Nurse (RN) with a current Alabama license and an Associate Degree in Nursing (ADN). Additional Requirements: Bachelor of Science in Nursing (BSN) must be obtained within three (3) years of hire as a condition of employment. BLS certification. Citi Program Training to be completed within first 90 days. Preferred: ACLS (Advanced Cardiovascular Life Support) certification, with ONS (Oncology Nursing Society) or equivalent clinical research certification.

Experience
Required: A minimum of 5 years of nursing experience. Preferred: 1+ years of experience in clinical research, including IRB submissions, reporting, source documentation, and trial management.

Regulatory and Ethical Knowledge
A thorough understanding of regulatory requirements, Good Clinical Practice (GCP), and biomedical research ethics is preferred.

Interpersonal and Communication Skills
Strong interpersonal skills with the ability to interact effectively with stakeholders, including staff, sponsors, regulatory bodies, patients, and referral sources. Must be able to read, write legibly, and communicate fluently in English.

Personal Attributes
Ability to work independently, demonstrating initiative and independent judgment in decision-making. High attention to detail, with strong prioritization and time-management skills.

Work Environment
Capable of making critical decisions under stress. Able to work effectively under pressure and with frequent interruptions.

WORKING CONDITIONS

Work Context
Requires the ability to coordinate and/or lead others while managing difficult interactions with people, including external customers. Involves exposure to human body fluids and chemicals. Typically involves working 40 hours per week, with occasional requirements to work beyond regular hours for special circumstances (e.g., urgent matters such as serious adverse events).

Physical Factors

• Light Work: Exerting up to 20 pounds of force occasionally, up to 10 pounds frequently, or negligible force constantly to move objects. Light work may involve arm/leg controls but primarily involves sitting.
• Physical Abilities: Requires dynamic flexibility, stamina, and static strength.
• Physical Activities: Talking, hearing, bending, twisting, walking, kneeling, crouching, stooping, reaching, pushing, pulling, lifting, grasping, repetitive motion, standing, and using hands for object control.
• Other Requirements: Physical presence onsite is essential. Hearing and vision must be normal or corrected to normal range. Must be able to perform all duties with or without reasonable accommodation.

Other Job Factors

• Cognitive Abilities: Includes deductive and inductive reasoning, oral and written comprehension and expression, problem sensitivity, selective attention, speed of closure, and time-sharing.
• Psychomotor Abilities: Requires finger and manual dexterity, along with wrist-finger speed.
• Sensory Abilities: Must have speech clarity, speech recognition, and visual color discrimination.
• Work Styles: Includes adaptability, analytical thinking, attention to detail, concern for others, cooperation, dependability, independence, initiative, integrity, leadership, persistence, self-control, and stress tolerance.
• Work Values: Emphasizes achievement, independence, relationships, and support.

Safety Factors

• Performs essential job functions in a manner that ensures the safety of patients, visitors, and employees.
• Identifies and reduces unsafe practices that may result in harm to patients, visitors, and employees.
• Recognizes and takes appropriate action to reduce risks and hazards to promote safety for patients, visitors, and employees.