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Clinical Research Operations Manager (Remote)

Elligo Health Research
Austin, TX
  • Posted: over a month ago
  • Full-Time
Job Description

JOB SUMMARY

The Operations Manager (OM) is a member of the Research Operations team with process and personnel responsibilities. He/she will direct and oversee a group of Study Managers and work in collaboration with the Research Operations Program Management leaders to ensure successful conduct of clinical trials at Elligo clinics. This person will work closely with the Director, Research Operations and other Research Operations leadership to ensure all sites and studies are adequately and appropriately resourced and delivered efficiently to timeline, budget and quality expectations. The OM will provide study management expertise and mentor Study Managers. This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills.
This person will have overall responsibilities for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals, including:
• Develop strong working relationships and maintain effective communication with study team members
• Supervises, mentors and trains other study coordinator/managers
• Develop strong working relationships and is the point of contact for study coordinator/managers, clinics and sponsors for study and clinic related activities
• Provides supervision of study coordinators/managers on multiple concurrent trials and multiple site locations
• From time to time, may assist with clinic assessments during the clinic development stage
• Provide constructive feedback for many new company initiatives
​​​​​• Provide input to feasibility on proposals for potential new studies
• Ensure operational excellence and integrity through adherence with Elligo policies and procedures, client requirements, GCP, ICH, FDA, EMA and all relevant international regulatory requirements

Study Coordination of Clinical Trials including:
• Completes all protocol related training
• Perform patient/research participant scheduling
• Collect patient/research participant history
• Collects and maintains source documentation
• Performs data entry and query resolution
• Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-- clinical supply materials, imaging and laboratory handling manuals, etc.).
• Adhere to an IRB approved protocol
• Assist in the informed consent process of research subjects.
• Support the safety of research subjects, report adverse events.
• Coordinate protocol related research procedures, study visits, and follow--up
• Assist with the screening, recruiting and enrollment of research subjects.
• Facilitate pre--study, site qualification, study initiation, monitoring visits, and study close out activities
• Collect, process and ship laboratory specimens
• Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines.

QUALIFICATION AND EDUCATION REQUIREMENTS
• At least 6 years of experience coordinating clinical trials, including the activities listed above
• BS/BA in Life Science or related discipline
• Previous nursing experience in a clinical setting a plus
• CCRC or CCRP certification a plus
• Previous GCP training and certification required
• Demonstrated ability in positive relationship building, with strong verbal and written skills required.
• Previous experience with training and mentoring other clinical research professionals is required
• Strong interpersonal skills with attention to detail
• 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, pre-study site visits, attend investigator meetings or vendor visits/audits, as required
•Strong organization/prioritization skills for the management of multiple concurrent projects

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. Regular local and regional 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.
 

Elligo Health Research

Address

Austin, TX
78738 USA

Industry

Science

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