Research Regulatory Assistant

Employment: Research Regulatory Assistant

Type: Full Time

Location: 2130 W. Holcombe Blvd, .10th Floor, Houston, Texas 77030, TX

"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 Assistant functions as an integral part of the Research Team to support the daily operations of the clinical trial management at Oncology Consultants, P.A. under the general supervision of the Research Regulatory and Compliance Manager and the Research Department Administrator.

SCOPE:

The Research Regulatory Assistant will facilitate document flow to ensure timely completion and distribution of study documents for all clinical trials at Oncology Consultants.

Shift Schedule:

• Mon - Fri: 8am - 5pm

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:

• Represents Oncology Consultants in a professional and courteous manner when interacting with staff, sponsors, IRBs, Principal Investigator, Sub-Investigators, and patients/subjects.
• Assist to complete feasibility questionnaires for proposed clinical trials as needed.
• Set up various meetings (Protocol Review and Feasibility Committee, Site Qualification Visits, Site Initiation Visits, Monitor Visits, etc.) as needed.
• Enter study-specific information on forms and documents received from Sponsor, IRB, and the Research Department staff as required in preparation of document submissions.
• Maintain study documents in our electronic regulatory files in SharePoint and in the non-electronic Study Investigator Files for clinical trials being conducted at Oncology Consultants once a study is approved by the IRB.
• Assist to distribute new study documents to appropriate staff when received and provide submission status of the items.
• Complete various documents (such as but not limited to: Delegation of Authority Logs, Form FDA 1572s, Financial Disclosure Forms, etc.) for clinical studies being conducted.
• Maintain the files with current certifications and ranges for all laboratories being used in the conduct of the clinical trials.
• Maintain the files with current CVs and Medical Licenses for investigators.
• Maintain the files with current training documents (GCP, HRS, etc.) for investigators, research and supporting staff.
• Work with Research Coordinators to ensure training documentation provided to Regulatory Department is accurate.
• Receive incoming correspondence/files and review/forward to appropriate staff.
• Attend Site Qualification Visit meetings, Site Initiation Visit meetings, and other meetings as applicable.
• Perform a variety of administrative duties including but not limited to: answering phones; faxing and filing of confidential documents; and basic Internet and email utilization.
• Prepares for the archival of clinical trial documents/records on site or off site for long term storage.
• Set up access for Sponsors and their representatives (monitors, auditors) in OncoEMR once the Site Initiation Visit has occurred in preparation for routine monitor visits. Collaborates with study coordinator to prepare regulatory binders and documents for monitoring visits and audits. Ensures that the regulatory binders are current prior to monitor visits.
• Enter basic data from source to electronic data capture systems

ADDITIONAL DUTIES AND RESPONSIBILITIES:

• Receive, open and distribute study related correspondence, packages and boxes.
• Abides by all HIPAA regulations.
• Maintains confidentiality of sponsor protocols and related documents.
• Participates in educational and training activities.
• Other duties may be assigned to meet business needs.

EDUCATION and/or EXPERIENCE:

• High school diploma or higher.
• One year experience in a medical or research setting preferred but not required.
• Proficiency with Microsoft Word and Adobe Acrobat.

. LANGUAGE SKILLS:

• English
• Excellent verbal and written communication skills

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 automobile approximately 15% 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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