White Rock Medical Center is a community-based hospital located near the historic White Rock Lake community, that serves the Dallas, Garland, Mesquite and surrounding areas. We specialize in a wide range of services including comprehensive medical/surgical care, bariatric, cardiology, outpatient and emergency medicine. Our mission is to deliver exceptional healthcare with compassion and excellence. White Rock Medical Center is seeking compassionate, care-minded individuals to join our company and make a difference. As a member of the White Rock Medical Center team, you can advance your skills while working in a supportive and patient focused environment. Apply today! Why join White Rock Medical Center? Competitive salary and benefits Employee programs and events. Paid Time Off and 7 Company Holidays. Employer paid life insurance. Additional voluntary benefits such as STD, LTD, etc. Job Summary The Research Study Coordinator is responsible for the coordination, administration, and execution of clinical research studies within a healthcare facility. Their role involves collaboration with research teams, healthcare professionals, sponsors, and study participants to ensure the successful implementation and conduct of research projects while adhering to regulatory and ethical standards. A Research Study Coordinator is a vital member of a healthcare research team, contributing to the advancement of medical knowledge and patient care by ensuring the successful conduct of clinical research studies. Essential Functions
Study Planning and Design: - Collaborate with Principal Investigators (PIs) and study sponsors to develop research protocols and study plans.
- Assist in the creation of study budgets and timelines.
Participant Recruitment and Informed Consent: - Identify and recruit eligible study participants.
- Obtain informed consent from participants and provide information about the study.
- Maintain contact with study participants and manage their study-related activities.
Data Collection and Management: - Collect and record data as per the study protocol.
- Ensure the accuracy and integrity of study data.
- Maintain organized and confidential study records.
Regulatory Compliance: - Maintain awareness of regulatory requirements and ethical standards (e.g., FDA, ICH-GCP, HIPAA) and ensure compliance.
- Prepare and submit required regulatory documents for study approval and monitoring.
Coordination and Communication: - Coordinate study activities with other research staff and healthcare professionals.
- Act as a liaison between the research team, study sponsors, and relevant stakeholders.
- Provide regular updates and reports to PIs and sponsors.
Study Monitoring and Quality Control: - Implement quality control measures to ensure data accuracy.
- Monitor study progress and resolve issues as they arise.
- Participate in site visits and audits by regulatory authorities or sponsors.
Adverse Event Reporting: - Report any adverse events or deviations from the study protocol to the appropriate authorities and ethics committees.
Documentation and Reporting: - Maintain comprehensive study documentation and records.
- Prepare and submit study progress reports as required by regulatory agencies and sponsors.
Communication/Knowledge
- Wears nametag properly; follows dress code policy; answers phone correctly and promptly; is prepared for meetings; meets deadlines; does not participate in gossip; acts ethically and treats others with respect; respects customer's and co-worker's time; establishes and maintains effective relationships with customers and co-workers.
Collaboration/Teamwork
- Attends staff meetings; follows HIPAA guidelines; follows patient rights policy; complies with the compliance program; demonstrates knowledge of role in a disaster; demonstrates knowledge of fire and fire drill procedures; working knowledge of hospital emergency codes; always utilizes standard precautions in the clinical setting; safely manages the environment of care by demonstrating a working knowledge of the requirements of the: Life Safety program, Utilities Management program, Hazardous Materials program, Emergency Preparedness program, Safety Management program, Medical Equipment Management program, Security Management program.
Requirements Experience
- Bachelor's degree in a related field (such as life sciences, nursing, or healthcare) preferred.
- Minimum 3 years previous experience in clinical research or a healthcare setting preferred,
- Knowledge of research regulations and ethics.
- Strong organizational and communication skills.
- Attention to detail and the ability to work independently and as part of a team.
- Proficiency in using research-related software and tools.
- Certifications: Some positions may require or prefer certification, such as Certified Clinical Research Professional (CCRP) or other relevant certifications.
Education/Licensure and Certification
- Bachelor's degree in a related field (such as life sciences, nursing, or healthcare) preferred.
- CCRP or CITI certification