Clinical Research Coordinator - Biltmore Campus - Asheville

Mountain Area Health Education Center; Biltmore (FL); Presencial; USD 52 000 - 64 000; Tempo integral

Resumo da oferta

Mountain Area Health Education Center in Asheville, NC, seeks a Clinical Research Coordinator to manage day-to-day activities for human subjects research and clinical trials under the PI and Clinical Research Nurse Manager. The CRC ensures compliant, efficient study conduct in line with GCP, IRB approvals, and MAHEC policies.

Responsibilities cover feasibility through closeout, including recruitment, consent, data and regulatory management, monitoring, and collaboration with sponsors, monitors,

Qualificações

• Bachelor’s degree or equivalent in health sciences or related field.
• At least 1 year of clinical research/ data coordination experience.
• Knowledge of GCP, HIPAA, informed consent processes and IRB procedures.

Responsabilidades

• Coordinate study activities from feasibility to closeout with appropriate oversight.
• Develop IRB-approved recruitment and retention strategies; prescreen, schedule, and follow participants.
• Escalate deviations, safety concerns, or regulatory issues to PI or licensed clinician as required.
• Prepare and maintain regulatory files, source documentation, and study records in inspection-ready state.
• Ensure data entry into approved systems and maintain data integrity per ALCOA+ principles.

Conhecimentos

Clinical research

GCP

HIPAA

Informed consent

Data coordination

IRB submissions

Formação académica

Bachelor’s degree in health sciences or related field

RN license or clinical credential (preferred)

ACRP or SoCRA certification (preferred)

Ferramentas

Electronic Medical Records

EDC systems

Clinical trial management systems

Sponsor portals

Descrição da oferta de emprego

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.

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 elevate 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. Ability to complete and maintain documented training appropriate to assigned responsibilities, including GCP, human-subject protection, HIPAA, conflict of interest, protocol-specific procedures, computerized systems, informed consent, biosafety, shipping, equipment, and other task-specific or protocol requirements before independently performing assigned activities. Ability to obtain and maintain applicable dangerous-goods shipping training, including IATA training when assigned duties require it, within the established onboarding period. Applicants must be authorized to work in the United States without current or future employer-sponsored work authorization for this position. PREFERRED QUALIFICATIONS: Two or more years of clinical research experience, preferably with industry-sponsored interventional studies. Experience with recruitment, informed consent, source documentation, EDC entry, query resolution, IRB submissions, monitoring visits, investigational-product accountability, specimen processing or shipping, and study closeout; ACRP or SoCRA certification; Experience with remote participant follow-up, electronic consent, wearable or connected devices, or other technology-enabled study activities; Experience performing phlebotomy, vital signs, EKG acquisition, laboratory specimen processing, or other protocol-required procedures; Current, unrestricted RN license or another relevant clinical credential, with experience applicable to the assigned research activities; Experience in diabetes, endocrinology, primary care, behavioral health, or another therapeutic area relevant to MAHEC’s research portfolio. CERTIFICATIONS Professional licensure is not required; however, candidates with an active RN license or another relevant clinical credential are encouraged to apply. When the position incumbent holds an applicable license or certification, related activities must remain within the individual’s current credential, demonstrated competency, institutional policy, protocol requirements, and documented delegation.

SCHEDULE

Regular attendance on-site is an essential function of this position. Typical business hours are Monday – Friday, 8:00 am to 5:00 pm (or flexed to best meet the needs of the clients and/or the Division); 40 hours per workweek; weekend, holiday, or evening coverage is occasionally required. Work hours will need to be flexible in order to respond to special work assignments, or evening activities, as requested by the team leader.

COMPENSATION

$58,000 annually (exempt) + MAHEC Total Rewards Package

At MAHEC, we strive to equip all team members with Total Rewards (pay + benefits) to honor their service, support their health, manage their financial security, build their career, and thrive. MAHEC is a qualifying employer for the Public Service Loan Forgiveness (PSLF) Program. Employees who meet federal requirements may be eligible to have remaining student loan balances forgiven after 10 years of qualifying payments while working full-time at MAHEC.

All MAHEC employees and learners will be required to receive the Flu vaccine or have an approved exemption.

Thank you for your interest in employment with Mountain Area Health Education Center in Asheville, NC, where we are committed to improving health in western North Carolina through innovative health professions education and compassionate healthcare. MAHEC was established in 1974 to improve training and retention of healthcare professionals across our region. We are dedicated to excellence in clinical care, health professions education, and innovative practices that can be replicated nationally. The largest of the nine state AHEC's, MAHEC serves NC's 16 westernmost counties to address national and state concerns with the supply, retention, and quality of health professionals especially in rural areas.