Senior Coordinator, Clinical Studies - Investigational Cancer Therapeutics
- Requisition #: 171804
- Department: Invest. Cancer Therapeutics
- Location: Houston, TX
- Posted Date: 11/26/2024
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 2022-2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
The primary purpose of the Senior Coordinator, Clinical Studies position is to provide independent and advanced patient care services and operational management for clinical trials. Impacts research protocols and the patients enrolled in designated protocols. Ensures strict adherence to the policies and procedures of the institution.
KEY FUNCTIONS
1. Coordination and oversight of activities related to clinical trials.
· Coordinate, evaluate, and follow the patient's participation in clinical settings. Provide collaborative oversight for the multidisciplinary team as necessary to document patient care, achieve objectives of phase I trials, and maintain patient safety.
· Instruct co-workers in allied fields in procedures for recording patient information.
· Participate in maintaining data necessary for audits, supervise audits, and oversee coordination of FDA audits.
· Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
· Provide leadership for the overall effective operation of designated protocols, which includes development, design, and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor.
· Provide leadership for a multidisciplinary team to effectively meet protocol goals.
· Act as the point of contact for all external and internal agencies.
· Supervises day-to-day operations to ensure smooth functioning of the ICT lab. Plans workload distribution, directs workflow and provides quality control to ensure accurate sample collection, processing, performing ECG, and shipment according to specific protocol requirements.
· Schedules personnel coverage and coordinates the delegation of work assignments for nightshift, weekends, and institutional holidays. Initiates changes in work schedules to assure adequate coverage during absences or staffing shortages. Manages these schedules to ensure adequate coverage while avoiding unnecessary overtime.
· Assumes responsibility for coordinating daily patient research schedules, reconciling performed assessments, and following up on patient related issues. Maintains an accurate daily log of all the patients and procedures scheduled for lab visits; follows up on queries to clarify reasons, and documents all such findings.
2. Coordination of quality control on clinical research studies.
· Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
· Ensures implementation of adequate quality control measures to avoid missing protocol-specified assessments. Interacts with data entry personnel to ensure all daily performance data is captured in the database.
· Ensures implementation of adequate quality control measures to guarantee that all research related procedures are conducted according to protocol requirements.
· Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
3. Direct support to clinical trial research protocols.
· Implements cross training on complex processing lab samples for team.
· Provides initial assessment and evaluation of the performance LT.
· Participates in the hiring process of LT, evaluates competencies, and makes hiring recommendations to the lab supervisor.
· Orients new employees as to their responsibilities and the ICT lab policies and procedures. Ensures all new hires complete mandatory training courses. Counsels' employees with regard to problems encountered in daily operations.
· Schedule patient tests: keep patients informed about test results and studies.
· Assist in obtaining consent for studies.
· Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies.
· Propose and implement new process improvement projects that will increase the study or lab efficiency and productivity
· Ensures all lab equipment is in working order at all times, schedules routine maintenance and repair of lab equipment. Ensures all sponsor-provided equipment is properly certified by the Biomedical Department prior to usage.
· Ensures adequate quantities of daily supplies are on hand at all times. Works with the lead to place monthly orders and monitors inventories. Ensures the inventory room is in order at all times.
· Ensures compliance with all regulatory and safety standards and enforces policies and procedures. Conducts regular lab safety audits and keeps records of these audits. Ensures adherence to hygiene and infection control standards.
· Provide support for labor-intensive protocols as needed.
· Collect or facilitate the collection of specimens as outlined in assigned protocols upon request:
· Process samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures.
· Develop and maintain database for tracking specimens with high level of accuracy.
· Serve as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.
· Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
4. Oversee, coordinate, and participate in the collection and evaluation of data for principal investigators.
· Monitor the retrieval of protocol-related data as documented in the medical record and ensure accurate entry into a computerized database or on a handwritten case report form.
· Generate PDMS data reports, protocol summary reports, and user-generated data reports as requested.
· Compile protocol and other data for manuscript submissions.
· Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.
· Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at training meetings.
· Additional projects, as assigned.
5. Training and mentoring.
· Train and mentor new study coordinators and data coordinators to perform the functions delineated in their position descriptions.
· Assist with supervisory functions such as counseling employee in regard to institutional policies and procedures.
· Provide input for performance evaluations.
· Provide training and guidance with regard to the policies and procedures that are related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings. Monitor accuracy compliance by study coordinators and data coordinators by performing QA audits.
· Plan, design, and conduct complex professional and ancillary staff education and disseminate information by means of training sessions/presentations and/or written communications.
· Conduct department training sessions to ensure protocol compliance and dissemination of new information and policies.
6. Other duties as assigned.
The performance for all expected outcomes is measured by observation by supervisor, reports from physicians 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 program and take the initiative in making decisions and taking actions to further these goals.
The above functions require the following abilities and skills:
· Must be able to read, interpret, and process large quantities of printed information. Must possess the ability to be clearly understood by verbal communication in face-to-face encounters and by telephone, read printed and written data, assimilate pertinent information in order to compose written correspondence. Must have a strong command of the English language and be able to communicate well verbally and in writing. Must be able to understand verbal and written directions. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis. Must be able to respond and assist other employees and visitors, as required.
· Must have the ability to travel to and from different destinations, including inpatient and outpatient care areas. Must also be able to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, lifting, etc.
EDUCATION
Required: Bachelor's degree.
Preferred: Master's degree.
EXPERIENCE
Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.
Preferred: Experience as a Coordinator, Clinical Studies.
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 Senior Coordinator, Clinical Studies position is to provide independent and advanced patient care services and operational management for clinical trials. Impacts research protocols and the patients enrolled in designated protocols. Ensures strict adherence to the policies and procedures of the institution.
KEY FUNCTIONS
1. Coordination and oversight of activities related to clinical trials.
· Coordinate, evaluate, and follow the patient's participation in clinical settings. Provide collaborative oversight for the multidisciplinary team as necessary to document patient care, achieve objectives of phase I trials, and maintain patient safety.
· Instruct co-workers in allied fields in procedures for recording patient information.
· Participate in maintaining data necessary for audits, supervise audits, and oversee coordination of FDA audits.
· Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
· Provide leadership for the overall effective operation of designated protocols, which includes development, design, and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor.
· Provide leadership for a multidisciplinary team to effectively meet protocol goals.
· Act as the point of contact for all external and internal agencies.
· Supervises day-to-day operations to ensure smooth functioning of the ICT lab. Plans workload distribution, directs workflow and provides quality control to ensure accurate sample collection, processing, performing ECG, and shipment according to specific protocol requirements.
· Schedules personnel coverage and coordinates the delegation of work assignments for nightshift, weekends, and institutional holidays. Initiates changes in work schedules to assure adequate coverage during absences or staffing shortages. Manages these schedules to ensure adequate coverage while avoiding unnecessary overtime.
· Assumes responsibility for coordinating daily patient research schedules, reconciling performed assessments, and following up on patient related issues. Maintains an accurate daily log of all the patients and procedures scheduled for lab visits; follows up on queries to clarify reasons, and documents all such findings.
2. Coordination of quality control on clinical research studies.
· Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
· Ensures implementation of adequate quality control measures to avoid missing protocol-specified assessments. Interacts with data entry personnel to ensure all daily performance data is captured in the database.
· Ensures implementation of adequate quality control measures to guarantee that all research related procedures are conducted according to protocol requirements.
· Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
3. Direct support to clinical trial research protocols.
· Implements cross training on complex processing lab samples for team.
· Provides initial assessment and evaluation of the performance LT.
· Participates in the hiring process of LT, evaluates competencies, and makes hiring recommendations to the lab supervisor.
· Orients new employees as to their responsibilities and the ICT lab policies and procedures. Ensures all new hires complete mandatory training courses. Counsels' employees with regard to problems encountered in daily operations.
· Schedule patient tests: keep patients informed about test results and studies.
· Assist in obtaining consent for studies.
· Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies.
· Propose and implement new process improvement projects that will increase the study or lab efficiency and productivity
· Ensures all lab equipment is in working order at all times, schedules routine maintenance and repair of lab equipment. Ensures all sponsor-provided equipment is properly certified by the Biomedical Department prior to usage.
· Ensures adequate quantities of daily supplies are on hand at all times. Works with the lead to place monthly orders and monitors inventories. Ensures the inventory room is in order at all times.
· Ensures compliance with all regulatory and safety standards and enforces policies and procedures. Conducts regular lab safety audits and keeps records of these audits. Ensures adherence to hygiene and infection control standards.
· Provide support for labor-intensive protocols as needed.
· Collect or facilitate the collection of specimens as outlined in assigned protocols upon request:
· Process samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures.
· Develop and maintain database for tracking specimens with high level of accuracy.
· Serve as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.
· Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
4. Oversee, coordinate, and participate in the collection and evaluation of data for principal investigators.
· Monitor the retrieval of protocol-related data as documented in the medical record and ensure accurate entry into a computerized database or on a handwritten case report form.
· Generate PDMS data reports, protocol summary reports, and user-generated data reports as requested.
· Compile protocol and other data for manuscript submissions.
· Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.
· Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at training meetings.
· Additional projects, as assigned.
5. Training and mentoring.
· Train and mentor new study coordinators and data coordinators to perform the functions delineated in their position descriptions.
· Assist with supervisory functions such as counseling employee in regard to institutional policies and procedures.
· Provide input for performance evaluations.
· Provide training and guidance with regard to the policies and procedures that are related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings. Monitor accuracy compliance by study coordinators and data coordinators by performing QA audits.
· Plan, design, and conduct complex professional and ancillary staff education and disseminate information by means of training sessions/presentations and/or written communications.
· Conduct department training sessions to ensure protocol compliance and dissemination of new information and policies.
6. Other duties as assigned.
The performance for all expected outcomes is measured by observation by supervisor, reports from physicians 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 program and take the initiative in making decisions and taking actions to further these goals.
The above functions require the following abilities and skills:
· Must be able to read, interpret, and process large quantities of printed information. Must possess the ability to be clearly understood by verbal communication in face-to-face encounters and by telephone, read printed and written data, assimilate pertinent information in order to compose written correspondence. Must have a strong command of the English language and be able to communicate well verbally and in writing. Must be able to understand verbal and written directions. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis. Must be able to respond and assist other employees and visitors, as required.
· Must have the ability to travel to and from different destinations, including inpatient and outpatient care areas. Must also be able to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, lifting, etc.
EDUCATION
Required: Bachelor's degree.
Preferred: Master's degree.
EXPERIENCE
Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.
Preferred: Experience as a Coordinator, Clinical Studies.
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: 171804
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 65,000
- Midpoint Salary: US Dollar (USD) 81,000
- Maximum Salary : US Dollar (USD) 97,000
- FLSA: non-exempt and eligible for overtime pay
- Fund Type: Soft
- Work Location: Hybrid Onsite/Remote
- Pivotal Position: Yes
- Referral Bonus Available?: No
- Relocation Assistance Available?: Yes
- Science Jobs: No
#LI-Hybrid
