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 Coordi na tor ,   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   support s   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, develop s   effective recruitment strategies, coordinat es   participant protocol   treatment schedules, and   participat es  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 , e xecute   the   informed consent process, e xplaining 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   dispos ition   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, scan ning , upload ing   study-related documentation per protocol, procedural manual, and MAHEC protocols and   policies
- Obtaining , process ing , and ship ping   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 maint enance 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

- R equires 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).

- K n owledge   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.

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   exp ertise   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.

If you are interested in this role, and you have related experience and qualifications, we encourage you to apply or reach out to   [email protected]   for support in your job search process. You could be the talent we are   seeking   for this or other opportunities

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