Clinical Trials Assistant

Attention! This job posting is 124 days old and might be already filled.
This job posting was marked by employer as filled and is probably no longer available

Clinical Trials Assistant

Date Posted June 20, 2018
Job Type Regular
Hours Per Week 40
PAVIR Job ID ADM1808.18
Salary Range DOE

Description

PAVIR engages in the administration of funds and providing support for the conduct of clinical research at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) to find new and improved ways to combat human disease and help people with disabilities. We are currently seeking a Clinical Trials Assistant (CTA) to work under the supervision of PAVIR’s Clinical Trial Program Manager and serve under the guidance/direction of VAPAHCS Principal Investigators and their research staff.

This position will learn about and assist with the implementation of all new and ongoing studies. The CTA plays a critical role at every stage of clinical studies and will have the opportunity to grow in the research field.  The CTA will be exposed to industry sponsors, will have direct interaction with prestigious Principal Investigators from different therapeutic areas, and will be exposed to all aspects of clinical operations of exciting clinical studies taking place at the VAPAHCS.  The CTA will act as the administrative foundation in supporting different aspects of clinical studies, which includes facilitating clinical trials from inception, implementation, and closeout.

This is a regular (40 hours a week), non-exempt (hourly paid) position.

PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved Without Compensation (WOC) appointment with VAPAHCS and complete a background check before they can commence work.

Duties:

Study Start Up:

  • Assist Clinical Research Coordinator (CRC) with collection of study documents (e.g. protocol signature pages, 1572s, PI CVs), scheduling and coordination of Pre-Site Selection Visits (PSV) and Site Initiation Visits (SIV).
  • Receive sponsor-specific training for Electronic Data Capture (EDC) system(s) and serve as back-up to CRC for data entry.
  • Review protocol and schedule of events to set up subject reimbursement schedule in online system.
  • Assist with the coordination and logistics of receiving study materials from the sponsor.

Study Maintenance:

  • Ensure timely entry of subject visit data and respond to query resolution in sponsor-specific EDC system.
  • Assist CRC in subject follow-up visit including scheduling collection of quality-of-life questionnaires, processing and shipping of laboratory and pathology specimens.
  • Help with the maintenance of Trial Master Files for monitoring visits, final reconciliation and archival.
  • Act as a central contact for the team for designated project communications, correspondence and associated documentation.
  • Liaise between CRC, PI, and PAVIR Accounting for the reconciliation of subject reimbursement as needed.

Regulatory and Compliance:

  • Assist CRC in the initiation and renewal of IRB application and R&D Committee Submissions.
  • Prepare for internal and external audits.
  • Address all queries generated during monitoring visits while monitor is on site.
  • Maintain CT.gov registration records of clinical trials being conducted at VAPAHCS. Communicate with study staff for the timely entry of data in CT.gov and address queries as needed.

Study Closeout:

  • Coordinate the study closeout visit with the sponsor.
  • Assist the CRC prepare the EDC system for data lock.
  • Help CRC with various administrative tasks related to pharmacy and laboratory closeout activities including reconciliation of drug and temperature logs, shipment of unused collection kits
  • Assist the CRC closeout the IRB, R&D, and PAVIR accounting.
  • Responsible for study record archival and tracking of materials sent to DataSafe per protocol.

Other:

  • Maintain internal processes, including accurate qualitative and financial data input and data maintenance, participate in department activities and process improvement activities as appropriate.
  • Contribute and help maintain Standard Operating Procedures for department and position.

Requirements:

Education:

  • Required: Bachelor’s Degree in Biological Sciences or equivalent

Work Experience:

  • Required: 0 – 1 year of related experience;

Knowledge / Skills / Abilities:

During the interview you will be asked to perform a task or take a test for Aptitude/Analytical abilities and Clinical Research Knowledge.  This will be used to assess candidates’ level of detail orientation and ability to extract complex information and apply it to specific case studies.  Hiring decisions will not be solely based on the outcomes of this assessment, but will be used to help the selected candidate be placed and trained accordingly.

  • Ability to prioritize and organize a high-volume workload and adapt to changing priorities
  • Familiarity with standard concepts, practices, and procedures within the research field
  • Excellent interpersonal, verbal, and written communication skills
  • Outstanding organizational skills
  • Ability to work independently
  • Ability to assume responsibility for professional self-development
  • Proficient with Microsoft applications (Word, Excel, and Outlook), mainframe computer applications, and database management

Preferred:

  • Knowledge of IRB, FDA, and other sponsors requirements.
  • Knowledge of VA and its health care system regarding clinical research trials and understanding of VA procedures and safety issues highly desired

Environmental Conditions / Physical Demands:

Physical: Lifting, standing, bending, repetitive movement, etc.

Environmental: Exposure to an office/clinical environment, office equipment, and some wet lab.

PAVIR engages in nonprofit medical research and works with sponsors and the Veterans Affairs Palo Alto Health Care System (VAPAHCS) in administering funds for conducting research to find new and improved ways to combat human disease and help people with disabilities. Please refer to our website for additional information: www.pavir.org

PAVIR is pleased to be an Equal Opportunity Employer for minorities, women, protected Veterans, and qualified individuals with a disability. If you need special assistance or an accommodation to apply for a posted position, please contact our Human Resources department.

Benefits

  • Sick Pay
  • 401(k) Retirement Plan with Company Match and Profit Share
  • Employee Assistance Program
  • Commuter Benefits
Please complete the information below and upload your documents (i.e. cover letter and resume / curriculum vitae) as ONE document for this specific position.
upload file … Limit reached, delete at least one file above to add more.  

You may only upload a file with the following file type: .doc, .docx, .txt, or .pdf
How did you find us?
Please choose one
U.S. Equal Employment Opportunity / Affirmative Action Information
YOUR PARTICIPATION IS VOLUNTARY

The Palo Alto Veterans Institute for Research (PAVIR) is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

It would greatly facilitate our compliance with Federal and State Equal Employment Opportunity / Affirmative Action guidelines if you would complete the information below. Completion is voluntary and this information will be kept confidential and separate from your application.

EEO is the Law. Click here to view information on your protections under Federal Law from discrimination.

In addition, PAVIR is a government contractor subject to the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) and we request information regarding an applicant’s protected veteran status in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classifications of protected categories are as follows:

  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran’s discharge or release from active duty in the U.S. military, ground, navel, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

If you believe you belong to any of the categories of protected veterans listed above, please indicate by making the appropriate selection.

Form CC-305
OMB Control Number 1250-0005
Expires 1/31/2020

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Autism
  • Bipolar disorder
  • Post-traumatic stress disorder (PTSD)
  • Deafness
  • Cerebral palsy
  • Major depression
  • Obsessive compulsive disorder
  • Cancer
  • HIV/AIDS
  • Multiple sclerosis (MS)
  • Impairments requiring the use of a wheelchair
  • Diabetes
  • Schizophrenia
  • Missing limbs or partially missing limbs
  • Intellectual disability (previously called mental retardation)
  • Epilepsy
  • Muscular dystrophy

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job by contacting hr@pavir.org. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Certification of Resume Submission

By selecting the checkbox below, I am certifying all the information I have provided with my application is true and complete to the best of my knowledge. I understand that all PAVIR employees must complete a “Without Compensation” (WOC) appointment through the VA Research Administration office, which includes fingerprinting, a background check, training, and verification of my education background (including licensure if required for the position I am applying for).

I understand that the information and materials I have submitted as part of the resume submission process is subject to verification and I hereby authorize PAVIR to verify the information provided with my resume submission. Further, I certify that I understand that if I am hired, any misrepresentations, falsifications, or omissions may be grounds for termination of my employment with this organization.