PHYSICIAN ASSISTANT I / TIMI STUDY GROUP

The TIMI Study Group Physician Assistant, in collaboration with their supervising physician, has responsibility for assessment and management of TIMI trial subjects enrolled at BWH and Partners related affiliates, including oversight of trial interventions, and continuous implementation and evaluation as per trial protocol guidelines. The Physician Assistant has acquired specialized knowledge and skills through completion of an accredited Physician Assistants program. The incumbent is accountable to collaborate, review with, and update the Principal Investigator regarding the status of each assigned trial.

This position is responsible, within the legal limitations, for assisting the TIMI Principal Investigators in the provision of research services in a variety of treatment areas including the main ED, outpatient hospital clinics, inpatient units, as well as Partners-related affiliates. The PA must work collaboratively with TIMI coworkers and study team members by utilizing advanced practice skills and knowledge to effectively enhance the research services provided by the TIMI Study Group.

The physician assistant works under the supervision of an attending physician and reports directly to the department director and department administrator.

Clinical:

1. Identify, recruit and consent eligible subjects for enrollment.

1. Arrange and perform screening visits or prescreen by chart review.
2. Performs subject care according to mutually agreed upon practice guidelines, and in accord with current guidelines per state and hospital regulations.
3. Performs and records subject evaluations such as past medical history, social history and habits, review of systems, physical assessment, and discusses findings with Principal Investigator.
4. Oversees/assures completion of procedures and tests, particular to the trial
   population, which are mutually agreed upon with the supervising physician.

1. Collaborates with Principal Investigators, research coordinators, and other TIMI and hospital personnel to safely implement the study protocol and coordinate resources.
2. Orders medications and writes prescriptions in accord with current protocol guidelines, organizational and regulatory policies and procedures.

1. Responsible for subject teaching, distribution of study medications, scheduling subject visits and follow-up visits as per protocol.
2. Monitor hospitalized subjects with daily visits and ensure high quality data collection.
3. Receives subject telephone calls, and is available by pager for questions from providers caring for study subjects.
   11. Communicate with the Principal Investigators and TIMI Director regarding study progress, enrollment, and lost-to-follow-up cases on a regular basis.

1. Incorporates the concepts of health maintenance, prevention, and promotion into daily practice through subject education and counseling.
2. Perform other duties as required and appropriate.
   
   Administrative
   

1. Oversee administrative procedures with the BWH Institutional Review Board (IRB), other hospital groups and study sponsors. Assist in completing and submitting IRB applications as well as Annual Continuing Reviews.
2. Prepare for and represent TIMI for site visits and audits (Sponsor, monitor, FDA). Serves as primary contact for study monitor. Serves as lead for monitor visits and quality review of data and files.
3. Oversee system for tracking experimental drug supplies and appropriate storage.
4. Learn the process involving and maintain correspondence with, the IRB, FDA, and other regulatory agencies. Maintain files and computer databases on study participants.
5. Abstract data from patient's medical records for completion of research chart and case report forms (CRF). Complete, submit, and maintain case report forms in a timely manner.
6. Respond to queries regarding incomplete data, and serious adverse event (SAE) reporting.
7. Participates in departmental quality improvement program. Utilizes quality improvement data and research findings to enhance subject care.
8. Attend weekly staff meeting.
   
   Coordination
   

1. Demonstrates appropriate collaborative and consultative relationships with other providers within TIMI and the hospital community.
   
   Personnel Management
   

1. Participates in interviewing, hiring, evaluation and supervising of TIMI Research Coordinators.

1. Provides input into evaluation of other staff as appropriate.
2. Responsible for training designated TIMI research staff as to protocols and procedures.
3. Supervises TIMI Research Coordinators involved in subject enrollment\retention process.
   
   Education
   

1. Participates in orientation and training of designated TIMI research staff as to trial protocols.
2. Participates in Departmental and organization continuing education programs.
3. Identifies own learning needs and updates clinical knowledge and skills through formal and informal education and review of current literature.
4. Educates lay and/or professional groups through lectures, papers, publications, and educational materials.
5. Attends\participates in TIMI Grand Rounds and Core Curriculum Educational Lecture Series.
   
   Planning
   

1. Develops annual objectives, and reviews same with supervising physician at time of performance review and at appropriate intervals. Completes required credentialing process, following BWH policy.
2. Assists in determining, evaluating, and/or implementing research area goals and objectives.
3. Maintains current knowledge of legislation that may affect the health care delivery system, clinical trial research in particular.
   
   Research
   

1. Participates in select TIMI research projects at a level consistent with
   educational background and experience.
   
   Quality Improvement
   

1. Contributes to guiding the direction of continuous quality improvement and research.
2. Assists in establishing and monitoring trial SOP's as they relate to this position, evaluates outcomes, makes recommendations for changes, and works to implement changes under the direction of their physician supervisor.
3. Collects, documents, and analyzes study participant data as necessary for QI monitoring.
4. Advocates for quality of care.
   
   Other

1. Assists in orienting new staff and evaluating clinical competence of staff.
2. Provides leadership and coaching as appropriate.
3. Practices professional behavior at all times.
4. Appropriately interacts and communicates with all members of the healthcare team, subjects, and families.
5. Takes direction well and understands own limitations.
6. Demonstrates good ethical judgment.
7. Performs other related duties as assigned or directed to meet the goals and objectives of the organization.

Education Requirements:

1. Must have 4 years of college level education and bachelor's degree or equivalent. (BS/MS joint programs are also acceptable).
2. Must have successfully completed a Graduate Level, accredited Physician Assistant Program approved by AMA Board of Approval and Certification of PA programs.

License/Certification/Registration Requirements:

1. Board Certification by the National Commission on Certification of PAs (NCCPA) is required.
2. License as a Physician Assistant in Massachusetts
3. Maintain current DEA and Massachusetts Controlled Substance Licenses
4. Complete 100 hours of CME according to national and state regulations during each 2 year period of employment.
5. Maintain current BLS/ACLS certification
6. Complete BWH Professionalism Program within 3 months of date of hire.
7. As necessary, complete additional certification such as BWH Procedural Sedation Training, e

1. Each PA shall demonstrate the following professional knowledge and skills:
   
   
   
   1. Interpersonal skills needed for interacting effectively with physicians, staff, trial subjects, and their family.
   2. Analytical skills needed for evaluating study participants and coordinating study procedures in accordance with each protocol.
   3. Is a strong team player, and supports other providers and offers help to the group.
   4. Proficiency in BWH computer systems as needed to independently perform daily tasks such as order entry, EMAR, lab tests and results, incident reporting, BICS, etc.
   5. Ability to consistently provide high quality and timely documentation, including admission notes, progress notes, discharge summaries, and dictation.
      
      
   
   
   
   
2. PA should demonstrate the following physical and mental abilities required.
   
   
   
   1. Must be energetic, quality driven and have proven ability to be a productive member of a cohesive team of peers, dedicated to providing optimum patient care.
   2. Understanding of trial procedures, policies and documentation required to ensure compliance with trial, FDA, and hospital standards.
   3. Ability to accept instructions and guidance and assume graded responsibility in a complex environment.
   4. Professional attitude towards patients and co-workers at all times and a collegial working relationship with other personnel involved in TIMI Study Group trials.
      
      
   
   
   
   
3. Each PA shall demonstrate the following clinical knowledge, skills and competencies:

1. Must exercise the highest degree of professional judgment under the direct supervision and guidance of a licensed physician.
2. For the most common diagnoses admitted to research, demonstrate competency to effectively diagnose, formulate appropriate treatment plan, and efficiently implement the plan without much direction, and with a greater level of independence, from the attending physician.
3. Broad knowledge of medical environment, standard research procedures, and performance goals.
4. Ability to administer high quality care and treatment and exercise such independent originality in solving problems not covered by existing guidelines, within legal limits, to meet the needs of the trial subjects.

Work areas will include BWH hospital clinics, various inpatient and outpatient units, as well as at Partners-related affiliates.

Job responsibilities will require significant amounts of standing, moving between rooms and floors, and communicating verbally and in writing with colleagues, trial subjects, and family members. Subject interaction may require standard precautions, and in some cases additional precautions as necessary.

Oversee the work of research coordinators assigned to trials.

Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.