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Pulmonary Hypertension Research Coordinator

GW Medical Faculty Associates | Washington, DC

Posted Date 10/30/2024
Description

Position Summary

The Pulmonary Hypertension research specialist is a key member of the Cardiac Pulmonary Hypertension (PH) Service line.  This position will have primary responsibility for coordination of clinical trials.   The position will support and act as a resource to the Pulmonary Hypertension health care team. The research specialist will perform clinical and administrative procedures including data collection and tracking, billing.  Specifically, they will need to build and manage all ONCORE related procedures.  The position will ensure that GWMFA research projects adhere to regulatory and clinical research guidelines.  The candidate will be responsible for all IRB activities involving PH research projects, including initial approvals, amendments, reportable events, and closures as appropriate. The specialist will need to manage the practice registry, the pulmonary hypertension association registry, and our biorepository.  This individual strives to achieve positive patient care outcomes throughout the disease process by practicing according to the standards of care and procedures and policies provided by GW Medical Faculty Associates.

 

Essential Duties and Responsibilities to perform this job successfully, and individual must be able to perform each essential duty satisfactorily.  Other duties may be assigned.

 

The Research Coordinator performs the following duties/responsibilities for the assigned Practice Area:

  1. Maintain updated files on all on-going IRB studies and protocols including the correspondence of informed consent forms, marketing materials, and data collection forms.
  2. Maintain secure files on all protected study related data.
  3. Maintain updated information on study progress and participate in recruitment, consent, follow-up and other study procedures.
  4. Maintain a schedule of IRB related deadlines for annual study renewal and closure.
  5. Help with study related follow-up calls when appropriate.
  6. Work with investigators on submitting study results at investigational meetings for publication.
  7. Maintain files on all presented and published study results.
  8. Maintain updated documentation of all IRB required CITI training.
  9. Facilitate additional research items including but not limited to study registration on clinicaltrials.gov and assistance with Investigational New Drug (IND) items.
  10. Facilitate grant submissions and requests for funding.
  11. Ensure compliance with research protocols and federal regulations.
  12. Maintain Manual of Operations for clinical trials.
  13. Establish Data and Safety Monitoring Boards.
  14. Assist in tracking site enrollment, performance information, and subject study status. Establish methods to track follow and maintain subjects.
  15. Screen and enroll research participants, obtaining informed consent, including a review of medication histories to see if subjects are eligible for enrollment, conduct interviews with subjects, help patients to enter data on research data sheets (also known as eCRFS) and enter in the REDCap database. The research coordinator will schedule/arrange all activities related to research visits and act as a liaison between patients, physicians and staff members.
  16. Additional duties include assisting the PI with day-to-day affairs of the site activities as they relate to the clinical management of the Clinical Trial.

 

Regulatory/Policy

  1. Demonstrates awareness and compliance with GWMFA and GW Hospital policies and procedures.
  2. Complies with standards and regulations of licensure, regulatory and accrediting agencies.
  3. Knowledge or medical research standards, protocols, and regulations applicable to the position/Practice area.
  4. Competes all required regulatory training by ASCR and required for individual trials
  5. Manages IND submission and the regulatory INDs with the PH Director.

 

Other Duties

The Research Coordinator may also:

  1. Perform other duties as needed to support the timely completion of research projects that are consistent with established protocols.
  2. Participate in preparation of new research proposals.
  3. Work together with others in the study protocols, such as research coordinators, physicians and technicians.
  4. Serves on appropriate MFA and Hospital committees, providing leadership about pulmonary hypertension initiatives
  5. Provides consultation in pulmonary hypertension specialty area to patient care teams and multidisciplinary team members, coordinating pulmonary hypertension research care between inpatient and outpatient settings (including GWUH)
  6. Prepares for PH Association accreditation procedures as it applies to research with the Director of the PH Program

 

Professional Development:

  1. Determines own professional needs through on-going self-assessment and evaluation of role performance and assumes responsibility for meeting those needs.
  2. Attends relevant workshops, conferences and seminars, locally and nationally.
  3. Belongs to appropriate professional and/or specialty organizations, keeping abreast of current research regarding pulmonary hypertension
  4. Disseminates professional contributions in lectures and seminars.

 

Minimum Qualifications

The requirements listed below are representative of the knowledge, skill, and /or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education         

A bachelor’s degree preferred or equivalent combination of training and experience. ACRP-CCRC Certification preferred.

Experience     

Three + years' experience in clinical research preferred as well as applicants with previous clinical research background.  

Competencies

The requirements listed below are representative of the knowledge, skills, and/or traits required for success in this position.

Research Coordinator must demonstrate:

  • Knowledge and support of GWMFA’s vision, mission statement, values, and guiding principles.
  • Current knowledge of medical research standards, protocols, and regulations applicable to the position/Practice Area.
  • Excellent interpersonal skills for communicating professionally, cheerfully, and effectively with study participants, families, physicians, and coworkers.
  • Good written communication skills for the preparation of coherent research summaries.
  • Proficiency reading documents and following instructions written in English.
  • The ability to work well with others across differences and resolve conflicts when they occur.
  • Familiarity with the technology/equipment utilized by the research project.
  • Compassion, patience, and calm.
  • Integrity, with appropriate concern for confidentiality.
  • Flexibility, initiative, and self-direction.
  • Attention to detail and ability to manage multiple priorities.
  • Concern for quality and accuracy.

 Physical Requirements

  • Sit, stand, bend, reach, and walk for long periods of time in an office setting.

  • Must be able to occasionally lift, carry, push, or pull over 100 lbs. as part of the role.

  • Requires manual dexterity to operate a computer keyboard, calculator, copier machine, and other equipment.

Other Requirements

None at this time

 

Supervision Received

Department Research Physician Leadership and Senior Director of Clinical Research Operations. Direct collaboration with Physician Fellowship / Research Liaisons

Supervision Exercised

Supervision over data entry or support staff for research.

About GW MFA

MFA physicians provide comprehensive patient care, offering one practice for the whole person with 52 medical and surgical specialties. As members of the GW School of Medicine and Health Sciences faculty, MFA providers are teachers and mentors for medical students, residents, fellows, and researchers preserving the rich tradition of academics, research, and healing. In addition to maintaining a closely integrated alliance with The George Washington University and The George Washington University Hospital (GWUH) which is separately owned and operated by Universal Health Services (UHS), the GW MFA has active referring relationships with 12 area hospitals.

The GW MFA’s leading healthcare presence in the DC metro region is complemented by a network of community-based practices in DC, Maryland, and Virginia. Given its geographic location in central NW Washington, DC, and proximity to more than 175 resident embassies, the MFA continues to evolve its international clinical outreach.

Salary20.00 - 27.69 Hour
Job Type
Full-time

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