Research Operations Manager, Laredo, TX
Job Posting for Research Operations Manager, Laredo, TX at Elligo Health Research
JOB SUMMARY
The Research Operations Manager plays a key role in supporting the Project Leads to ensure aspects of project delivery goal and objective at all participating clinics are met to quality, timeline and budget expectations. This position will be accountable to the Project Lead for assigned responsibilities and will assist with the coordination of study operations across all Elligo clinics throughout protocol implementation, study conduct & maintenance, and study close-out.
QUALIFICATION AND EDUCATION REQUIREMENTS
WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
Moderate (10-25%) travel is required for this position.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.
The Research Operations Manager plays a key role in supporting the Project Leads to ensure aspects of project delivery goal and objective at all participating clinics are met to quality, timeline and budget expectations. This position will be accountable to the Project Lead for assigned responsibilities and will assist with the coordination of study operations across all Elligo clinics throughout protocol implementation, study conduct & maintenance, and study close-out.
- As directed by the Director, Clinical Operations or Project Lead, perform or coordinate awarded study launch activities including, but not limited to:
- Set-up and configuration of Clinical Conductor (or any other clinical trial management system) in collaboration with Finance, Proposals & Contracts and Innovation Team
- Set up of eISF for each clinic
- Set up of study conduct updates and metrics reporting
- Forecast of project timelines and resource requirements
- Establish study-specific processes to ensure consistent conduct of studies across all clinics
- In coordination with Project Leads, identify training needs, develop and deliver or ensure delivery of training to Study Managers and Study Coordinators when necessary, including new hires
- Coordinate study-specific documentation collection, review and archive with Study Managers at each clinic
- Assist in the development of clinic-specific patient recruitment targets and projections
- Collect, track and report on patient recruitment and study updates from SMs and SCs at the clinics and escalate issues when necessary
- Perform weekly review of Clinical Conductor data for timeliness and accuracy to ensure management reports are accurate
- Perform periodic quality reviews of eISF
- Assist Director, Research Operations to oversee Study Managers and Study Coordinators study activities at the clinics throughout the conduct of the project, including conducting field visits to review quality and performance.
- Serve as a back-up or additional resource for the Study Managers and Study Coordinators at the clinic, if needed
- Participate on process development initiatives as required.
- Assist with Study Managers and Study Coordinators recruitment and interviewing.
QUALIFICATION AND EDUCATION REQUIREMENTS
- At least 5 years clinical research experience
- BS/BA in Life Science or related discipline is a plus
- Previous nursing experience in a clinical setting a plus
- Previous and current GCP training
- Demonstrated ability in positive relationship building, with strong verbal and written skills required
- Strong organization/prioritization skills for the management of multiple concurrent projects
- Project management and organization skills a must
- Ability to work well under timelines and deliverable targets
- Strong interpersonal skills with attention to detail a must
- Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
- Ability to travel for Clinic activities, QC visits, training, company meetings, etc.
WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
Moderate (10-25%) travel is required for this position.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.
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