Director of Quality Assurance in Clinical Research
Posted Updated
About IHI
At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.
What You Will Do
The Director of Quality Assurance is responsible for:
- Oversight and continuous improvement of a clinical research quality management system in conjunction with IHI CEO and Medical Director, IHI Chief Clinical Officer, and the Chief Research Officer;
- Evaluations of existing studies through auditing;
- Development of training programs for new and existing research staff in collaboration with Research Education Coordinator;
- Ongoing maintenance and development of QA Standard Operating Procedures (SOPs) and Work Instructions (WIs) and review of other functional area SOPs relating to clinical research activities; and
- Oversight of internal investigations and CAPA program.
The Opportunity
- Conduct internal auditing activities to ensure research studies are performed in compliance with sponsor protocols, Good Clinical Practices (GCPs), SOPs, and applicable regulations.
- Document and report on audits. Create/produce audit certificates. As needed, review audit reports with applicable team members.
- Create, update, and maintain an annual audit schedule and review with individual team members.
- Develop and/or review standardized operational procedures (SOP’s) and workflows for research related topics ensuring quality through consistency.
- Conduct internal investigations developing Corrective and Preventive Action (CAPA) plans as needed. CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly.
- Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested.
- Develop training program for research staff (physicians, nurse practitioners, physician assistants, research nurses and study coordinators).
- Conduct advanced training for physicians and APPs interested in conducting research at IHI. Serve as mentor and advisor, reviewing study documents including IIS protocols.
- Conduct monthly topic specific QA presentations for all staff participating in research studies.
- Update research staff on new regulatory changes and new guidance documents.
- Participate in training of external, non-IHI personnel such as faculty of Partner’s Physician Academy.
- Member of Research Leadership Team. Participate in new study selection process, interviewing/hiring of new staff, discussing and resolving research related issues or concerns.
- Serve as research regulatory advisor for the research department for individual staff members or as a member of a variety of small discussion groups or committees where a research regulatory perspective is necessary.
- Able to supervise a small independent team of Research staff
- Perform other related duties as assigned.
Requirements
- Minimum Bachelor’s degree in related field. Preferred MS degree or higher.
- Minimum 12 years of clinical research experience with at least 5 years in GCP quality assurance leadership position
- Valid driver’s license and insured automobile required
This is a remote position with quarterly visits to IHI or as otherwise needed for on-site training or Center-specific or Research-specific needs. Travel to applicable conferences or meetings may be required.
Benefits
Why join our team?
IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package.
IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics.
IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.
IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHTC research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more.
Innovative Hematology, Inc. is an Equal Opportunity Employer.
Skills
As published by workable · 28 questions · 2 written answers
Basics
First name, Last name, Email, Headline, Phone, Address, Education, Experience, Resume, Cover letter
Short answers (14)
- What is your desired salary?
- How did you find out about this position? If an employee referral, please list their name.
- Have you ever been discharged from a job? If yes, please explain.
- If specified in the job posting, do you possess a valid driver's license and insured automobile? If this is not specified in the job posting, please list "N/A".
- As listed in the job posting, all IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role. Please initial below to indicate your understanding.
- Innovative Hematology, Inc. is an equal opportunity employer. Employment opportunity and position advancement shall extend to all people without regard to sex, race, color, religion, sexual orientation, disability, age, national origin, ancestry, military status, or any other legally-protected category. This policy includes, but is not limited to, employment, promotion, demotion, transfer, recruitment, recruitment advertising, lay-off, termination, rates of pay, other forms of compensation, and selection for training. Please initial below to indicate your understanding.
- Innovative Hematology, Inc. participates in the federal E-Verify program. All new employees must successfully pass an E-Verify Check. For more information about E-Verify, visit: www.e-verify.gov. Please initial below to indicate your understanding.
- Please share your current or most recent salary.
- I certify that all the information given by me on this Application or in supplemental form is true and correct to the best of my knowledge and belief. I further understand that false or misleading statements on this Application or supplemental forms are sufficient cause for my dismissal if I am hired. Please initial below to indicate your understanding.
- I acknowledge, agree, and understand that if any of the information is found to be false, it is grounds for disqualification or immediate dismissal. I hereby give permission to IHI or its affiliates to consult with previous employers, educational institutions, references and with other sources such as government databases (i.e. HHS/OIG/GSA) to verify the information contained within this application or provided by me on supplemental documents to learn of my ability and work history, and I authorize any such organizations or individuals to provide the requested information. I hereby release my previous employer, acquaintances and all other sources providing information to IHI or its affiliates, from all liability for any damage whatsoever resulting from issuing information concerning me. I also agree to release IHI or its affiliates from any claims I may have arising from their requests for information related to this application. Please initial below to indicate your understanding.
- I acknowledge, agree, and understand that none of IHI's or its affiliates' practices or policies are to be construed as imposing any binding obligations on IHI, and that they are subject to change or deletion at any time by IHI or its affiliates in its sole discretion. Please initial below to indicate your understanding.
- I acknowledge, agree, and understand that IHI or its affiliates reserves the right to require tests for alcohol or drugs during the course of my employment, consistent with applicable law, including but not limited to the Americans with Disabilities Act. I authorize any health care professional or testing facility who performs such an examination or who has other information concerning my test results to release such information to IHI or its affiliates and that drug test results with a positive outcome for any illegal substance will result in disciplinary action, up to and including termination of employment. Please initial below to indicate your understanding.
- I acknowledge, agree, and understand that should I be employed by IHI or its affiliates my employment is "at will", meaning that either party may end or terminate the relationship at any time for any reason, with or without notice or cause. There is no promise or guarantee of employment or that my employment will continue for any specific period of time. Any verbal discussions about my employment by IHI representatives are not binding upon IHI or its affiliates. My eligibility for specific terms and conditions of employment must be confirmed in writing by a duly authorized IHI representative. Please initial below to indicate your understanding.
- I acknowledge, agree, and understand that any offer of employment I may receive is conditioned on me successfully passing, to IHI's satisfaction, IHI's background check (including, but not limited to, criminal and civil) as well as any applicable fit-for position or other tests that IHI or its affiliates requires for the position I am seeking. Please initial below to indicate your understanding.
Pick from a list (12)
- What is your highest level of completed education?
- Do you have any professional licensures or certifications?
- Have you ever had action taken against your professional license? (If you do not have a professional license, write "no").
- Have you previously worked for IHI or affiliates or held contract employment for IHI?
- Are you 18 years of age or older?
- Have you served in the United States military? If so, please list branch and dates of service. If no, please enter "N/A"
- Can you perform the essential functions of this job without accommodations?
- Are you the parent or legal guardian of a minor (under the age of 18) that is currently or was a patient of IHI or its affiliates within the last five (5) years?
- Are you a current or former, within the last five (5) years, patient of IHI or its affiliates?
- Do you have any relatives who are currently employed by, or who worked in the past five (5) years for IHI or its affiliates?
- Are any relatives of yours (whether members of your immediate family or not) physicians that (1) are employed by IHI or its affiliates, (2) refer patients to IHI or its affiliates, or (3) are otherwise affiliated with IHI?
- Are you legally eligible for employment in the United States?
Written answers (2)
- If yes on the question above, please list licenses, issue date, and expiration date (if applicable). If no licenses or certifications, please enter "N/A"
- Please provide starting and ending salary for each role you have worked within the past 10 years.