Clinical Research Assistant - Part time, 24 hours per week - Pediatric Hematology/Oncology office - Kalamazoo, MI

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Location

BMH Bronson Methodist Hospital

Title

Clinical Research Assistant - Part time, 24 hours per week - Pediatric Hematology/Oncology office - Kalamazoo, MI

Under general supervision the Clinical Research Assistant is responsible for reviewing, editing, and updating the Children’s Oncology Group (COG) consent documents initiated by new study activations, amendments and annual reviews. The Research Assistant prepares documents of all study activity for Institutional Review Board (IRB) meetings, as well as, regularly organizes and updates hard files for office use and

regulatory audits.

Associate's degree required, Bachelor's preferred. Prior research experience preferred. Education in the protection of human  research  participants  and  Good  Clinical  Practices  preferred. 

IATA Certification for shipping infectious substances and diagnostic specimens

OTHER SKILLS & ABILITIES

o  Ability to learn complex concepts (regulatory, ethical, and scientific)
o  Excellent Microsoft Office and internet usability
o  Superior word processing, proof-reading, and editorial skills with regard to scientific
    documents
o  Ability to read and interpret research and clinical trial documents and instructions
o  Self-directed and detail-oriented with strong analytical and problem-solving skills
o  Advanced written and verbal communication skills
o  Excellent  interpersonal  skills  and  the  ability  to  work  constructively with physicians other related departments (pathology), and Bronson employees
o  Ability  to  work  effectively  and  efficiently  under  tight  deadlines,  high  volumes, and multiple interruptions with precision and adherence to clinical trial requirements

Works in a clean, well lit, and temperature controlled smoke-free environment.

Must be able be able to sit or stand at work station for up to two to three hours at a time, ability to  hear  within  normal  range  and  have  the  physical  capability  and  hand  dexterity  to  operate switchboard equipment and basic office equipment. Must be able to lift, carry, pull or push up to 25 pounds.

Must  have excellent  verbal  and  written  communication  skills.   Ability  to  maintain  positive customer service. Ability to establish effective working relations with office staff and employees in a team environment. Must maintain the highest level of confidentiality.  Effective prioritization skills and ability to manage time independently.

ESSENTIAL DUTIES AND RESPONSIBILITIES

o  Establish and organize study files, including regulatory binders and study specific source documentations
o  Maintain and update study files and retain all study records in accordance with sponsor requirements and institutional policies
o  Review, edit, and update scientific consent documents specific to each clinical trial
o  Collaborate with the PI to prepare the IRB and other regulatory submission documents
o  Assist in the review of eligibility criteria for subject enrollment
o  Coordinate the enrollment of participants into COG studies
o  Review  and  develop  a  familiarity  with  COG  protocols  following  study  guidelines  for specimen submission
o  Collect data as required by the protocol and assure timely completion of Case Report Forms
o  Other duties as assigned, may include, but are not limited to:
o  Coordinate  comprehensive  clinics  for  Hemophilia,  Sickle  Cell,  and  Hem/Onc
patients.
o  Coordinate  health  management  visits  for  patients  with  Children  Special
Healthcare.
o  Prep charts for comprehensive and management visits.

PERFORMANCE STANDARDS

I.  DOCUMENTATION: Demonstrates  the  competencies  associated  with  the  paperwork  or charting aspect of the job. For some jobs, e.g., clerical, this is a major function of the job.  For  others,  e.g.,  direct  patient care  jobs,  it  demonstrates  that  the  employee  documents their work appropriately and not how well the work is performed. Data is gathered from charts, notes, paperwork, completed documents, etc.

II.  JUDGMENT/DECISION  MAKING:  Demonstrates  the  ability  to  evaluate  the  factors relevant to a situation and make timely decisions that add value to the services provided.  Data is gathered from peer review, observation, customer comments/suggestions, etc.

III.  TECHNICAL  SKILLS: Demonstrates  competency  in  the  skills or  tasks  required  for  the employee’s job. Data is gathered via peer review, observation, etc.

IV.  TEAMWORK: Demonstrates the competencies necessary for developing and maintaining cooperative relationships with other at all levels of the organization by sharing information, workload  responsibilities, decision-making  and  recognition  of  others  in  pursuit  of  a common purpose. Evidence is gathered via peer review, observation, etc.

V.  PRODUCTIVITY: Demonstrates the ability to achieve the desired  work result effectively and efficiently with the minimum of time and resources. Evaluated through peer review, observation, etc.

VI.  QUALITY IMPROVEMENT: Demonstrates competencies necessary for the integration of quality control into the job, department and/or organization-wide improvements. Data is gathered through documented improvement processes.

VII.  COMMUNICATION  SKILLS: Demonstrates  appropriate  communication  skills  with patients,  visitors,  coworkers,  supervision,  physicians  and  others.   Includes  verbal  and telephone skills.  Data gathered via observation, workshop/presentation evaluation form, written or verbal feedback from customers.

VIII.  PROFESSIONAL  GROWTH: Participates  in  a  program  of  self-development  and continuous  education.   This  is  for  all  employee  mandatory  inservices,  other  inservices, educational activity, and community service as required by the job.  Data gathered from sign in sheets and department records.

IX.  EXTENDED  ROLES: This  itemizes  extended  roles  (if  any)  the  employee  performs,  i.e., charge, preceptor, etc. For each advanced role, a separate competency list is required.

X.  CUSTOMER  SERVICE: Demonstrates  adherence  to  the  standards  as  provided  in  the Bronson  “Commitment  to  Customer  Service”,  i.e.,  Commitment  Statements,  Quality Service Standards and the Interaction Process which includes the Service Recovery “AAA Action Plan”.  Data gathered via observations, customer  surveys,  and other written and verbal feedback from customers.

XI.  AGE  SPECIFIC (Direct  patient  care  jobs  only.):  The  employee  must  be  able  to demonstrate the competencies necessary to provide services appropriate to the age of the population served. Data gathered from observation and department records.

Shift

First Shift

Time Type

Part time

Scheduled Weekly Hours

24

Cost Center

7010 Pediatric Hematology/Oncology - Professi (BMH)

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