Job Details
"You can make a difference in the life of an oncology patient and find your career satisfaction by joining our team of healthcare professionals today."
About Oncology Consultants
Oncology Consultants has been a premier adult medical oncology & hematology practice in Houston, TX for over 40 years. Our healthcare team is committed to provide state of the art cancer treatment in a caring environment as we continue to expand our oncology services in the metropolitan region.
Oncology Consultants is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.
About the Position
The Research Regulatory Coordinator functions as an integral part of the Research Team in clinical trial management at Oncology Consultants, P.A. The Research Regulatory Coordinator is involved in multiple aspects of the research process under the general supervision of the Research Regulatory and Compliance Manager and the Research Department Administrator.
SCOPE:
The Research Regulatory Coordinator is responsible to support the clinical research activity and research staff through timely and accurate submission of regulatory and IRB documents for new and ongoing studies and to ensure that our research department is following all internal and external policies and regulations, including but not limited to IRB, SOPs, study sponsor, CRO, FDA, ICH and GCP guidelines. The primary focus is on accurate and timely preparation, submission, maintenance, filing and reporting of regulatory documents pertinent to research. Provides regulatory guidance and direction to internal clinical research programs to ensure compliance with all applicable policies, procedures, and regulations.
Shift Schedule:
Benefits:- Insurances: Life, medical, dental, short term and long-term disability
- 401K
- Free parking
- PTO
- Holidays
- Competitive salary
- Employee Assistant Program
- Tuition Reimbursement
- Continuing Medical Education Allowance
- Pet Insurance
Essential Duties and Responsibilities:Consistently exhibits behavior and communication skills that demonstrate commitment to superior customer service, including quality, care, and concern with every internal and external customer
- Represents Oncology Consultants, P.A. in a professional and courteous manner when interacting with staff, sponsors, IRBs, PI's, patients/subjects.
- Prepares, submits, and maintains timely and accurate regulatory documents to the IRB (sponsor selected central IRB or site selected IRB), sponsors and state or federal regulatory offices.
- Prepares, facilitates, submits, and maintains the process for accurate and timely submission of IRB applications for protocol revisions or amendments, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or to enrollment to studies for IRB approved protocols as required by the federal regulations and internal policy. This responsibility includes facilitating and coordinating all aspects of these submissions to include evaluating the protocol changes and incorporating those changes into the informed consent form in language understandable to the participant as required by the specific revisions made to the research protocol. Ensures that all documents are complete, and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB.
- Responsible for facilitating, communication and follow up to queries of the IRB, sponsor and other committees as a result of their review of regulatory submissions.
- Prepares applicable submission forms and submits updated documents including but not limited to: Amendments, Addendums, Investigator's Brochures, Safety Information, Form FDA 1572s and informed consent documents.
- Maintains and accurately files all regulatory documents and necessary logs within the regulatory binder(s) and in the site's SharePoint.
- Manages the archival of clinical trial documents/records on site or off site for long term storage.
- Collaborates with study coordinators to prepare regulatory binders and documents for monitoring visits and audits. Ensures that the regulatory binders are current prior to monitor visits.
- Coordinate monitor visits with EMR access.
- Manages PI and Sub I Curriculum Vitae and to be current, signed and on file also, ensures medical licenses, advance practice nurse license, and Good Clinical Practice (GCP) certifications are current and on file.
- Abides by all HIPAA regulations.
- Maintains confidentiality of sponsor protocols and related documents.
- Creates error free written documents and reports (e.g., cover letters, notes-to-file, memos, etc.) and ensures Research Regulatory and Compliance Manager and/or the Research Department Administrator approve and sign these.
- Performs all duties timely as required by the GCP per federal regulations.
- Assists the Research Department Administrator with study feasibility questionnaires.
- Other duties may be assigned to meet business needs.
ADDITIONAL DUTIES AND RESPONSIBILITIES: - Participates in educational and training activities.
- Attends continuing education offerings.
EDUCATION and/or EXPERIENCE: - Degree in the life sciences or health sciences such as associates or bachelor's in science,
- Minimum of 2 year in any one area or combination of areas including the field of medicine, clinical research, business administration and document management/control.
- Communicate effectively verbally and in writing.
- Be moral and ethical in decision-making and during interactions with patients, sponsor representatives, IRB representatives, physicians, and research staff other employees.
- Be motivated to identify tasks that need to be completed and to strive for accuracy and quality when completing assignments.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Work is performed in an office environment and requires frequent interaction with the research and non-research staff, physicians, patients, study sponsors and regulatory agencies.
Work will require limited travel by air or automobile approximately 25% of time such as to other locations within the practice or investigators meetings.
COMMENTS: This description is intended to describe the essential job functions, the general supplemental functions, and the essential requirements for the performance of this job. It is not an exhaustive list of all duties, responsibilities, and requirements of a person so classified. Other functions may be assigned, and management retains the right to add or change the duties at any time.
LANGUAGE SKILLS: Proficient in written and verbal E
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