HCA, Hospital Corporation of America Research Coordinator in Aurora, Colorado

Position Summary

The primary function of the Clinical Research Coordinator is to coordinate the conduct of cardiovascular clinical research protocols in the clinic and in-hospital settings with emphasis on the screening, enrollment and monitoring of study subjects for Aurora Denver Cardiology Associates, P.C.

Position Responsibilities

The Research Coordinator has the following responsibilities:

1. Serves as primary study coordinator for research protocols in the outpatient clinic or at affiliated hospital as assigned by the Director. 2. Directs the conduct of clinical studies to ensure adherence to the research protocol. 3. Screens patient records, databases and physician referrals for identification of prospective candidates for research protocols. 4. Interviews prospective subjects for participation in investigations and obtains informed consent. 5. Participates in initiation visits/investigator meetings for assigned clinical trials (may involve travel) and implements these trials according to a deadline schedule mutually agreed upon by PI and sponsor. 6. Educates human subjects for participation in investigations. 7. Educates clinic/hospital personnel for participation in protocol conduct, data collection process and related issues as applicable. 8. Ensures all study personnel have completed required training and training is documented, before conducting protocol related activities. 9. Maintains consistent enrollment in protocols and provides monthly, written documentation of screening/enrollment/follow-up activities. 10. Coordinates the collection of data according to the research protocol, operation manual and case report form guidelines within the budgetary guidelines established by the Director. 11. Draws,*processes,*prepares and ships laboratory samples for clinical trials. 12. Maintains investigational drug/device dispensing accountability and shipping logs according to protocol guidelines. 13. Performs ECG’s, Holter monitoring and other procedures as directed by study protocol. 14. Instructs Principal Investigator on procedures and tests that need to be performed in compliance with the study protocol and advises PI on the results of procedures and testing; calling to attention findings of clinical importance. 15. Documents research related examinations, procedures, tests and other activities in appropriate clinic or hospital charts. 16. Document phone conversations with sponsors, study subjects, physicians and coordinating organizations. 17. Schedules follow-up visits for study subjects with appropriate personnel in and provides source documentation for activities conducted during these visits. 18. Completes accurate and complete data entry into case report forms or pre-established computer programmed formats. 19. Schedules and undergoes*Coordinates and participates in*sponsor initiated monitor visits and quality assurance audits for periodic reviewing and querying of collected data in a timely manner. 20. Identifies strategies to improve patient enrollment in research protocols in collaboration with the PI. 21. Report all serious or unexpected adverse events immediately to physician or Research Director,*maintains documentation and review of AE’s.* 22. Assist in reporting all serious or unexpected adverse events to appropriate regulatory agencies (sponsor, IRB) in a timely manner. 23. Assists in maintenance of patient flow sheets and research data base

In addition to above, the Research Coordinator 1. Identifies areas for continuing education.

2. Actively promotes an open line of communication and a professional relationship with all members of the organization. Utilizes appropriate resources to resolve problems. 3. Ability to prioritize an organize high volume workload and changing priorities
  1. Acts in accordance with The Practices principles and practices.
  2. Performs delegated duties as assigned.

Standards of Performance

Standard I: Proficiency & Competency 25%

*A. *Acquire and maintain basic knowledge of Good Clinical Practice and FDA guidelines for the conduct of clinical trials. *B. *Assisting in assurance of patient safety and well-being. *C. *Gaining thorough knowledge of assigned protocols. *D. *Assisting in development of project specific tracking forms, work sheets and patient scheduling forms. *E. *Maintaining good source documentation per sponsor guidelines for all data entered in Case Report Forms. *F. *Assisting in maintenance of patient flow sheets and research data base. *G. *Perform and track subject stipends dispensed from Greenphire and perform sanction checks

*Standard II: Planning, Organizing and Evaluating 25% *

*A. *Identifying appropriate patients for protocols. *B. *Maintain good communication with staff, patients, Principal Investigator, sub-investigators and sponsor personnel. *C. *Consenting patients for protocols per guidelines. *D. *Develop methods of improving efficiency as each project evolves. *E. *Assisting in meeting timelines for enrollment and study completion. *F. *Completing and transmitting all Case Report Forms in an accurate, neat and timely manner. *G. *Reporting all serious or unexpected adverse events immediately to physician or Research Director. *H. *Assisting in reporting all serious or unexpected adverse events to appropriate regulatory agencies (sponsor, IRB) in a timely manner. *I. *Attending Investigator meetings as a representative of the research team. *J. *Scheduling of patient visits within appropriate windows per protocol and with appropriate personnel (physician, NP/PA, echo etc.)

Standard III: Leadership 10%

A. Demonstrates ability to serve as a role model. B. Motivates and fosters professional growth in self and co-workers. C. Clearly and effectively communicates expectations, goals and outcome measures to Management Staff. D. Creates a productive and positive work environment. E. Conducts self in a mature and responsible manner. F. Completes assignments and submits documentation in a timely manner. G. Consistently participates in patient-related and organizational meetings.

Standard IV: Professional Conduct 10%

A. Conducts self in a mature and responsible manner. B. Maintains the confidentiality of staff member’s issues.

Standard V: Judgment and Decision Making 10%

A. Manages multiple and changing priorities effectively. B. Sets goals, objectives and evaluates outcomes. Problem solves accordingly.

Standard VI: Relationships 5%

A. Demonstrates the ability to develop and maintain effective working relationships with all staff members and visitors. B. Collaborates with staff members to promote and maintain a productive work environment.

Standard VII: Initiative and Resourcefulness/Adaptability 5%

A. Demonstrates the ability to create, initiate and integrate new concepts and practices to achieve goals. B. Seeks appropriate solutions to problems. C. Demonstrates efficiency under stress. D. Demonstrates flexibility and adaptability to change. E. Willingly assists in other duties as assigned.

Standard VIII: Communication, Attitude and Cooperation 5%

A. Establishes and maintains open and effective communication patterns with staff, visitors, callers, physician and sponsor personnel. B. Deals with conflict in a constructive manner. C. Supportive of The Practices objectives, decisions, and policies. D. Seeks, accepts and profits from constructive criticism. E. Works with a positive attitude. F.

Standard IX: Professional Development 5%

A. Assumes accountability for maintaining and improving own professional knowledge and skills and is committed to own professional growth. B. Identifies areas for learning and pursues appropriate avenues for doing so. C. Prepares for taking and passing national certification exam for Research Coordinators (eligible after 2 years of experience).

Experience: *Medical field experience required,clinical research experience preferred. *

Education: College degree preferred or minimum five (5) years of practical work experience acceptable in lieu of education.* Willingness and ability to complete Athenahealth end user training required. Willingness to acquire certification through Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) within2*3years of hire.

Special Qualifications -Good computer skill, communication skills,excellent organizational skills,detail oriented,ability to function under tight project timelines. Athenahealth system proficiency desired.

Title: Research Coordinator

Location: Colorado-Aurora-Aurora Denver Cardiology

Requisition ID: 24090-59179