Coordinator, Research Data (Regulatory) - Investigational Cancer Therapeutics
- Requisition #: 172898
- Department: Invest. Cancer Therapeutics
- Location: Houston, TX
- Posted Date: 1/31/2025
The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2024-2025 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
The primary purpose of the Coordinator, Research Data is to provide administrative and patient care services for the coordination of research studies. Coordinates and gathers patient data for research studies.
KEY FUNCTIONS
1. To assist in the coordination of regulatory correspondence and maintenance of FDA-required documentation on all departmental clinical trials.
- Communicate verbally and in writing with pharmaceutical sponsors to address regulatory queries
- Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination.
- Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
- Maintain electronic filing system (Box) and ensure that appropriate personnel have access.
- Ensure timely completion and submission of IRB Annual Continuing Reviews and assist with any subsequent contingencies.
2. To coordinate research meetings and site initiation visits and inform department staff, as needed.
- Schedule research meetings and complete all related details, including obtaining equipment, making conference room reservations, and inviting appropriate speakers and collaborators.
- Generate documents on computer, using word processing, spreadsheet, and other software to produce professional appearance.
3. Other duties as assigned.
The performance for all expected outcomes is measured by observation by supervisor, reports from faculty and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goals of the department/program and take the initiative in making decisions and taking actions to further these goals.
The above functions require the following abilities and skills:
· Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and ability to interact effectively with patients and co-workers.
· Strong attention to detail.
· Strong organizational skills.
· Ability to work with personal computers using standard word processing software, spreadsheets, and programs for database and graphics usage.
· Ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds.
· Use of computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc. Use of push-button, multiple line telephone set. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)
· Be clearly understood by verbal communication in face-to-face encounters and by telephone.
· Strong command of the English language, including spelling, writing, and verbalizing and ability to communicate well verbally and in writing.
Working Conditions
This position requires:
Physical Demands
Indicate the time required to do each of the following physical demands:
EDUCATION
Required: High school diploma.
Preferred: Bachelor's degree in an appropriate scientific or administrative area.
EXPERIENCE
Required: Two years of related experience. With preferred degree, no experience required.
Preferred: Regulatory experience is a plus.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
#LI-Hybrid
The primary purpose of the Coordinator, Research Data is to provide administrative and patient care services for the coordination of research studies. Coordinates and gathers patient data for research studies.
KEY FUNCTIONS
1. To assist in the coordination of regulatory correspondence and maintenance of FDA-required documentation on all departmental clinical trials.
- Communicate verbally and in writing with pharmaceutical sponsors to address regulatory queries
- Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination.
- Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
- Maintain electronic filing system (Box) and ensure that appropriate personnel have access.
- Ensure timely completion and submission of IRB Annual Continuing Reviews and assist with any subsequent contingencies.
2. To coordinate research meetings and site initiation visits and inform department staff, as needed.
- Schedule research meetings and complete all related details, including obtaining equipment, making conference room reservations, and inviting appropriate speakers and collaborators.
- Generate documents on computer, using word processing, spreadsheet, and other software to produce professional appearance.
3. Other duties as assigned.
The performance for all expected outcomes is measured by observation by supervisor, reports from faculty and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goals of the department/program and take the initiative in making decisions and taking actions to further these goals.
The above functions require the following abilities and skills:
· Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and ability to interact effectively with patients and co-workers.
· Strong attention to detail.
· Strong organizational skills.
· Ability to work with personal computers using standard word processing software, spreadsheets, and programs for database and graphics usage.
· Ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds.
· Use of computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc. Use of push-button, multiple line telephone set. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)
· Be clearly understood by verbal communication in face-to-face encounters and by telephone.
· Strong command of the English language, including spelling, writing, and verbalizing and ability to communicate well verbally and in writing.
Working Conditions
This position requires:
| Working in Office Environment | | No | | X | Yes |
| Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic) | X | No | | | Yes |
| Exposure to human/animal blood, body fluids, or tissues | X | No | | | Yes |
| Exposure to harmful chemicals | X | No | | | Yes |
| Exposure to radiation | X | No | | | Yes |
| Exposure to animals | X | No | | | Yes |
| | | | | | |
Physical Demands
Indicate the time required to do each of the following physical demands:
| | Time Spent | ||||
| Never 0% | Occasionally 1-33% | Frequently 34-66% | Continuously 67-100% | ||
| Standing | | X | | | |
| Walking | | X | | | |
| Sitting | | | | X | |
| Reaching | | X | | | |
| Lifting/Carrying | |||||
| | Up to 10 lbs | | X | | |
| | 10lbs to 50 lbs | X | | | |
| | More than 50 lbs | X | | | |
| Pushing/Pulling | |||||
| | Up to 10 lbs | | X | | |
| | 10lbs to 50 lbs | X | | | |
| | More than 50 lbs | X | | | |
| Use computer/keyboard | | | | X | |
EDUCATION
Required: High school diploma.
Preferred: Bachelor's degree in an appropriate scientific or administrative area.
EXPERIENCE
Required: Two years of related experience. With preferred degree, no experience required.
Preferred: Regulatory experience is a plus.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
- Requisition ID: 172898
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 36,000
- Midpoint Salary: US Dollar (USD) 45,000
- Maximum Salary : US Dollar (USD) 54,000
- FLSA: non-exempt and eligible for overtime pay
- Fund Type: Soft
- Work Location: Hybrid Onsite/Remote
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
- Science Jobs: No
#LI-Hybrid
