Clinical Research Coordinator - Biltmore Campus - Asheville

JOB SUMMARY:

The Clinical Research Coordinator, under the guidance and supervision of the Principal Investigator (PI) and the Clinical Research Nurse Coordinator, supports the integrity and quality of human subjects research (clinical trials), maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and MAHEC policies and procedures. The Clinical Research Coordinator supports the coordination and timely handling of the operational aspects of the clinical research protocol, including pre- and post-research activities, in and outside the clinical setting. The Clinical Research Coordinator helps implement clinical research projects, develops effective recruitment strategies, coordinates participant protocol treatment schedules, and participates in recruitment, screening, scheduling, testing, and data management for multi-faceted investigations. The Clinical Research Coordinator typically works on multiple research projects simultaneously.

SPECIFIC RESPONSIBILITIES:

In general:

• Working as part of a multidisciplinary research team.
• Working as part of a multidisciplinary research team. Understand and perform trial work in accordance with Good Clinical Practice (GCP) standards.
• Support communication among interdisciplinary partners to support the development and execution of research and evaluation projects including MAHEC, Mission Health, and Community team members.
• Provide operational feedback to managing staff

Study Specific:

• Assist the clinical trials team in assessing the feasibility of and planning for each study.
• Perform clinical and administrative tasks in the implementation of clinical trials, which may include:
• Recruiting, enrolling, and scheduling participants in compliance with regulatory and monitoring agency standards and institutional guidelines
• In partnership with the Principal Investigator and Clinical Research Nurse Coordinator, execute the informed consent process, explaining studies to participants, answering questions, and documenting the consent process
• Assure compliance with receiving, monitoring, and documenting the dispensing of investigational drugs and devices, as well as drug and device disposition at study close
• Obtaining vital signs (e.g., blood pressure, pulse, oxygen saturation, weight), medical history, medication history, and other clinical data questionnaires
• Performing medication reconciliation and baseline clinical assessment
• Collecting biologic specimens
• Performing laboratory specimen processing
• Recording, scanning, uploading study-related documentation per protocol, procedural manual, and MAHEC protocols and policies
• Obtaining, processing, and shipping biological specimens according to protocol and IATA requirements
• Completing follow-up with study participants over phone, video conference, or in-person
• Providing participant education and responsive support with investigational drugs or devices and trial activities
• Understand and support operational procedures amendments and adverse event reports as required by the IRB and study sponsors
• Support the maintenance of study regulatory binder and participant charts according to protocol and/or institutional requirements
• Assisting investigators in organizing study data for progress reports and analysis
• Performing study closeout procedures per protocol

Perform other related duties and participate in special projects, as assigned

• Requires adherence to HIPAA regulations

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 trialssuch 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.

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.

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:

• Not Applicable.

EDUCATION AND EXPERIENCE

MINIMUM QUALIFICATIONS:

• Bachelor's Degree in a related field of study such as biology, health sciences, nursing, or a similar discipline, with at least 1-2 years of experience in a clinical research, healthcare, laboratory, or related setting.

- or -

An equivalent combination of education and experience, which includes:

• Licensure and experience as an Emergency Medical Technician (EMT), Paramedic, Pharmacy Technician, Licensed Practical Nurse (LPN), Associate Degree Nurse (AND) or Certified Medical Assistant (CMA), with a minimum of 3-5 years of experience in a healthcare, laboratory, or clinical research setting.
• 2-3 years of experience in clinical trials, data management, regulatory compliance, or a related research setting, preferably as a Clinical Research Assistant or similar role.
• Must complete CITI certification for Human Subject Research within 3 months of hire, if not already completed.

PREFERRED QUALIFICATIONS:

• SOCRA or ACRP certification preferred

COMPENSATION:

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

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.

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.

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