Clinical Research & Data Coordinator

Morehouse School of Medicine; Atlanta (GA); On-site; USD 42,000 - 64,000; Full time

Job summary

Morehouse School of Medicine seeks a detail-oriented Clinical Research & Data Coordinator to support precision medicine studies and clinical trial matching using EHRs for participant identification and data management.

The role oversees trial operations, data integrity, and collaboration between physicians and research teams to ensure secure access to clinical data and timely study activations.

Qualifications

• Experience with clinical research processes and human subjects protections.
• 2) Familiarity with EHR data standards, data integration, and data privacy implications.
• 3) Knowledge of regulatory requirements (IRB, HIPAA, GCP) and ethical considerations.

Responsibilities

• Oversee EHRs to identify and match study participants and screen/enroll for trials.
• Manage clinical trial data sets for accuracy and security and ensure timely data entry into EDC systems.
• Coordinate with researchers and physicians to implement health informatics solutions for trial enrollment.
• Maintain data standards and regulatory compliance across data management activities.
• Assist with data visualization and communication of clinical and real-world data to stakeholders.
• Collaborate on manuscripts, reports, and grants and present findings at meetings.

Skills

Clinical research

Data management

Regulatory compliance

HIPAA compliance

IRB procedures

EHR proficiency

CTMS

Data analysis

Communication

Time management

Project coordination

Tools

EHR systems

CTMS

EDC systems

Job description

Position Summary

Morehouse School of Medicine is seeking a highly motivated, detail-oriented Clinical Research & Data Coordinator to support the Precision Medicine Implementation studies like the Tulisokibart for Moderate to Severe Ulcerative Colitis Study. This pivotal role is responsible for facilitating the timely and accurate matching of participants to appropriate clinical trials, with an emphasis on leveraging electronic health records (EHRs) for participant identification and data management. The coordinator will oversee key aspects of clinical trial operations and assist with ensuring seamless and secure access to and utilization of clinical data. This includes managing study participant data, preparing for rapid clinical trial study activations, ensuring data integrity, and serving as a liaison between physicians, research teams, and other stakeholders. This position plays a vital role in advancing clinical research and improving patient access to clinical trials.

POSITION ACCOUNTABILITIES AND ESSENTIAL FUNCTIONS

Study Participant Management: Oversee the electronic health records (EHRs) to identify & match study participants and screening & enroll study participants for available clinical trials. Clinical Data Management : Manage clinical trial data sets, ensuring accuracy, consistency, and security. Ensure that all clinical trial data are accurately entered into electronic data capture (EDC) systems and in a timely manner, adhering to established protocols and guidelines. Study Coordination : Collaborate with researchers and physicians to implement health informatics solutions that support the enrollment of clinical trial participants. Study Compliance and Data Integrity : Maintain data standards, ontologies, and metadata frameworks in alignment with best practices and regulatory requirements. Ensure adherence to clinical trial regulatory requirements (IRB, HIPAA, GCP, etc.). Data Analysis : Assist with data visualization and communication of clinical and real world data to various stakeholders. Collaboration : Contribute to the drafting of manuscripts, reports, and grants, as well as present findings at scientific meetings and conferences.

KNOWLEDGE , SKILLS , & ABILITIES

Strong understanding of clinical research processes and human subjects research and protections. Understanding of clinical data, including data structures, standards, and ontologies. Familiarity with oncology trials and precision medicine concepts, particularly related to genomic testing and clinical trial matching. Working knowledge of electronic health records (EHRs), clinical trial management systems (CTMS), and data entry protocols. Awareness of ethical considerations related to the informed consent process and data privacy33. Also, familiarity with regulatory and ethical aspects of clinical research, including Good Clinical Practice (GCP) guidelines, Institutional Review Board (IRB) procedures, and Health Insurance Portability and Accountability Act (HIPAA) regulations. Ability to build and maintain positive working relationships across interdisciplinary teams. Ability to adapt quickly to changes in program needs, study protocols, and technology platforms. Ability to manage multiple tasks and projects simultaneously, set priorities, and meet deadlines. Ability to maintain confidentiality and protect sensitive patient and research data, upholding ethical standards and complying with all regulations applicable to clinical research.

CORE COMPETENCIES

Clinical Research Coordination: Understands clinical trial protocols, workflows, and regulatory compliance and coordinates multiple study components with precision and timeliness. Attention to Detail: Demonstrates accuracy in data entry, documentation, and review; identifies and resolves discrepancies in patient records and study data. Communication: Communicates clearly and effectively with internal and external stakeholders, including physicians, patients, and research staff, adapting messaging based on the audience and context (e.g., written, verbal, or electronic). Collaboration & Teamwork: Builds productive relationships across departments and with partner organizations and demonstrates a cooperative approach and willingness to support team goals. Patient-Centered Focus: Prioritizes patient safety, privacy, and access to appropriate clinical trials and demonstrates cultural sensitivity and empathy in patient interactions. Problem-Solving & Critical Thinking: Identifies operational challenges and proposes practical, evidence-based solutions; anticipates potential issues and takes proactive steps to minimize disruptions. Time Management & Adaptability: Manages shifting priorities in a dynamic research environment and remains flexible and calm under pressure, especially during rapid study activations. Ethical Conduct & Integrity: Upholds institutional and regulatory standards related to clinical research and handles confidential data responsibly and adheres to ethical principles. Technology Proficiency: Navigates clinical databases, electronic health records (EHRs), and research software efficiently and learns new digital tools and platforms as needed for trial coordination. Project Management: Demonstrates experience in coordinating and managing projects, ensuring objectives are met within set timeframes. Able to identify and allocate resources effectively and can anticipate and mitigate potential risks or delays.

Minimum Qualifications

Minimum 2-3 years of experience working with clinical data, particularly in a research or healthcare setting. Familiarity with EHR data standards, data integration, and the ethical/legal considerations surrounding data usage. Excellent analytical, problem-solving, and organizational skills. Superior communication skills, both written and verbal. MS Office Suite. Ability to prioritize tasks and work independently, as well as part of a multi-disciplinary team.