Clinical Research Coordinator - Biltmore Campus - Asheville

JOB SUMMARY

The Clinical Research Coordinator (CRC), under the oversight of the Principal Investigator (PI) and supervision of the Clinical Research Nurse Manager, coordinates day-to-day activities for assigned human subjects research and clinical trials involving human participants. The CRC supports safe, ethical, compliant, and efficient study conduct in accordance with ICH E6(R3) Good Clinical Practice (GCP), applicable regulations, IRB approvals, study protocols, and MAHEC policies. The CRC may support studies from feasibility and startup through recruitment, participant visits, data and regulatory management, monitoring, and closeout.

SPECIFIC RESPONSIBILITIES

Study Coordination and Quality

• Coordinate assigned study activities from feasibility and startup through implementation, participant follow-up, monitoring, and closeout, with oversight appropriate to the study, assigned responsibilities, and demonstrated competency.
• Review protocols, schedules of events, manuals, and study instructions; organize visits, deadlines, supplies, and required documentation.
• Apply a proportionate, risk-based approach that prioritizes factors critical to participant rights, safety, and well-being and the reliability of study results.
• Coordinate assigned activities involving sponsors, CROs, monitors, vendors, laboratories, the IRB, and internal partners; escalate performance, compliance, data-quality, or participant-safety concerns.
• Identify operational barriers and quality concerns, recommend practical solutions, and promptly escalate clinical, safety, regulatory, contractual, budgetary, or legal matters.

Participant Recruitment, Consent, and Visits

• Develop and implement IRB-approved recruitment and retention strategies; recruit, prescreen, schedule, and follow participants using approved materials and procedures; track screening, enrollment, visit completion, and participant follow-up; and communicate barriers to meeting study enrollment goals.
• Conduct or support the informed-consent process when qualified, trained, and delegated; explain approved study information, document the process, and facilitate access to the investigator or an appropriately qualified clinician for medical questions or individualized clinical guidance.
• Collect and document protocol-required information, including vital signs, medical and medication histories, questionnaires, and other study data, within the employee’s qualifications and delegated authority.
• Provide participant education and follow-up regarding approved study procedures, visit expectations, investigational products or devices, and study activities within the employee’s training and delegated role.
• Protect participant privacy, confidentiality, rights, safety, and well-being.
• Maintain accurate documentation and tracking of completed visits, procedures, participant payments, and other study activities to support financial reconciliation and sponsor billing.

Safety, Deviations, and Clinical Boundaries

• Recognize, document, and promptly communicate participant-reported symptoms, adverse events, serious adverse events, protocol deviations, and other potentially reportable information.
• Escalate deviations that may affect participant rights, safety, or well-being or the reliability of study results, and support corrective and preventive actions as assigned.
• Route clinical assessment, medical decision-making, eligibility determinations requiring medical judgment, treatment decisions, and causality determinations to the PI or an appropriately qualified licensed clinician.
• Perform study-related procedures only when qualified through education, training, demonstrated competency, applicable licensure or certification, institutional policy, protocol requirements, and documented delegation.

Regulatory, Data, and Computerized Systems

• Prepare and maintain regulatory files, participant research records, required logs, approvals, staff credentials, training and delegation records, protocol and consent versions, and other essential records in an inspection-ready state.
• Create and maintain source documentation and study records consistent with ALCOA+ data-integrity principles; enter data into approved systems and resolve queries accurately and within required timelines.
• Use approved electronic health records, EDC systems, clinical trial management systems, sponsor portals, and other research platforms according to assigned access and training. Protect credentials and promptly report access, security, system, or data-integrity concerns.
• Maintain study information in the appropriate source documentation, research record, or legal health record according to institutional requirements.
• Coordinate monitoring visits, provide authorized study records, track findings and action items, and complete or facilitate timely follow-up in collaboration with the PI and Clinical Research Nurse Manager.
• Prepare or support IRB submissions, amendments, continuing reviews, reportable events, and study closure activities in collaboration with the PI and Clinical Research Nurse Manager.

Investigational Products, Devices, and Specimens

• Support receipt, storage, temperature monitoring, inventory, accountability, reconciliation, return, and disposition of investigational products and devices as trained and delegated.
• Collect biological specimens only when trained, competent, authorized, and permitted by institutional policy.
• Process, package, track, store, and ship specimens according to the protocol, laboratory manual, biosafety requirements, and applicable shipping requirements.
• Administer, dispense, or clinically manage investigational products only when permitted by applicable licensure, demonstrated competency, protocol and pharmacy requirements, institutional policy, and documented delegation.
• Perform other related duties and participate in special projects as assigned.

KEY COMPETENCIES

• Communication Skills

Effectively and respectably communicate with other individuals, whether it be a colleague, patient, or patient’s family member and appropriately enumerate information in a manner easily understood by all parties. We do this to foster a culture of understanding between all parties, especially in complex and difficult situations, to ultimately provide the best care possible to our patients and their families.

• Decision Making

Ability to make the most appropriate decision in a given situation and then taking the next steps to ensure appropriate and timely completion. This requires conflict resolution skills, critical thinking skills, confidence in your ability to make the right decision in most situations. This also includes ability to prioritize your workday appropriately to ensure the most important tasks are completed on time.

• HealthCare Knowledge

Having the drive to keep yourself abreast and up to date on the new breakthroughs in your area of expertise and communicating them to the rest of the team, as appropriate. This also includes keeping up with your licensure and yearly training requirements within your area expertise along with MAHEC’s organizational training. Finally, the ability to apply the depth of knowledge maintained and gained through this process in real life scenarios as appropriate.

• Interpersonal Skills

Showing the ability to meet difficult situations with grace, professionalism, and understanding. Within your area of expertise, showing respect and showing empathy where appropriate with your colleagues, patients, and their family at all times, even when its most difficult to do so. This is done, in part, by effective listening, being your authentic self, showing responsibility and dependability, and being patient with others.

• Organizational Values

Adherence to MAHEC’s founding principles and incorporating them every day. This includes, among others, having integrity and accountability, reverence for other cultures and equitable practices, ability to manage change, and displaying a clear understanding of organizational dynamics. Doing these things creates a culture where people want to do the best for each other and gives personal ownership towards the goal of helping people in their time of need.

• Problem Solving

Having an analytical mind and ability to work autonomously to solve complex problems that may arise. The wherewithal to think logically through a difficult problem and come to an appropriate resolution for a given issue. This helps to drive continuous improvement by thinking through where we can improve in a novel way. Measures success by understanding where we are currently and where we want to go and then applying those new ideas to affect positive change.

SPECIFIED SKILLS

• COMPUTER
• Excellent skills in Microsoft Office including Word, Excel, PowerPoint, and database applications required.
• Experience with Electronic Medical Records
• OTHER
• Understanding of clinical trial processes, Good Clinical Practice (GCP), and regulatory requirements (such as FDA, IRB).
• Knowledge of research protocols, principles, and procedures related to clinical trials such as screening, interviewing, and case report forms; basic knowledge of experimental design, computerized information retrieval systems, and computer data management; ability to identify, produce, organize data; knowledge of or ability to learn ethics and regulatory procedures (e.g., informed consent process, data safety, and monitoring plans, principles of data collection and documentation) involved with clinical research; ability to work as a member of a project team.
• Working knowledge and practical application of source-documentation, data-integrity, and ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
• Ability to interpret complex protocols and study instructions; manage multiple studies, competing priorities, frequent interruptions, and firm deadlines; maintain accurate, audit-ready records; and recognize when reprioritization, guidance, or escalation is required.
• Ability to independently organize and complete assigned work, recognize limits of authority, seek clarification when requirements are uncertain, exercise sound judgment, and escalate concerns without delay.
• Clear, respectful, and accurate communication with participants, families, investigators, sponsors, monitors, vendors, and internal teams.
• Ability to establish professional rapport with research participants, communicate complex requirements in understandable language, and provide consistent follow-through throughout study participation.
• Proficiency with Microsoft Office and the ability to learn and use electronic health records, EDC systems, clinical trial management systems, sponsor portals, and other research platforms.
• Demonstrates integrity, accountability, confidentiality, adaptability, attention to detail, and consistent follow-through.

PHYSICAL DEMANDS

• Light - Moderate energy level: Lift and carry 25 - 35 lbs, Push/Pull 50 - 100 lbs (empty bed, stretcher, etc.)
• Physical Activity: Occasional (0 - 33% of Workday)

SUPERVISORY RESPONSIBILITIES

• This position has no supervisory responsibilities. The PI retains investigator oversight; the Clinical Research Nurse Manager retains assigned supervisory and program-level responsibilities.

EDUCATION AND EXPERIENCE

MINIMUM QUALIFICATIONS

• Bachelor’s degree in health sciences, public health, biology, psychology, clinical research, healthcare administration, nursing, or a related discipline, plus at least one year of relevant clinical research, healthcare, laboratory, regulatory, or data-coordination experience; or
• An equivalent combination of education, professional credentialing, and at least two years of directly relevant clinical research, healthcare, laboratory, regulatory, or data-coordination experience demonstrating the competencies required for the position.