Senior Clinical Research Project Manager
Sonic Healthcare USA

Job Info

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Job Functions, Duties, Responsibilities and Position Qualifications:

Job Summary:

The Clinical Research Senior Project Manager (CRSPM) will be responsible and accountable for the successful management of multiple service and product lines with primary emphasis on ARI's Research Service Division. The CRSPM will work in tandem with the other Project Managers, Lab Technicians/ Technologists and multiple Principal Investigators to oversee project fulfillment progress by managing day to day Clinical Research Coordinator (CRC) activity and Operations in the Research Laboratory in Las Vegas, NV. In addition, the CRSPM will also be responsible for managing site responses to client study related inquiries, provide extensive updates as well as collaborate on other client or project related issues. The CRSPM will be a key member of the ARI Management Team and collaborate on all issues and opportunities impacting ARI and provide meaningful input as necessary to further the company's endeavors and help achieve its goals.

Essential Key Responsibilities:

• Manage the processes associated with the evaluation, budgeting, administration, contracting, scheduling and orchestration of diagnostic validation protocols relevant to ARI's Research Services Division.
• Become familiar with all active study specifications and criteria associated with each and every active ARI Study. Prior to initiation of study, assist in introducing the studies to the assigned CRCs and Techs and making sure that all Study requirements, specifications and timelines are fully understood.
• Understand and manage associated costs related to ARI projects and product procurement and distribution. Conduct margin analysis of prospective projects to determine if project meets ARI profitability criteria.
• Work in tandem with Quality Assurance to assure the consistent quality output of ARI service and product lines.
• Manage the flow of data submitted by the assigned CRCs into the ARI electronic project management tool. Ensure that all live counts are up to date and ensure that all project data is entered accurately and in accordance with all specifications.
• Coordinate multiple Studies over multiple locations and travel to study locations as required and as necessary to assist in the implementation of protocols and to conduct Study oversight.
• Personally assume specific project management responsibilities as needed and required to ensure timely completion of active studies leading to successful attainment of ARI Goals and Objectives.
• Work with Project Managers, PIs and CRCs in providing timely responses to client new project inquiries and requests.
• Assist in the training and on-boarding of new (ARI and non-ARI) CRCs in the assigned geography. Work with the Management team to design and implement a training program resulting in equipping new CRCs with the knowledge, skills and resources necessary to operationalize ARI activities in their respective site locations.
• Help coordinate and lead weekly CRC Project Review Conference calls to review progress, compliance with specifications, project timing and address issues or concerns.
• Work with the Quality Operations Coordinator in assisting in the establishment and revisions of Standard Operating Procedures necessary to conduct daily business.
• Help to establish and monitor all Study related files and forms across the ARI network to ensure compliance with all IRB, CAP and related Federal Regulations. Assist in the establishment and maintenance of Study Site Regulatory Binders to be kept at each participating ARI site.
• Responsible for the completeness and accuracy of all CRC submissions of Data Spreadsheets or related forms prior to Quality Assurance review to ensure CRC compliance with Study specifications and HIPPA requirements prior to release of biospecimens to ARI clients.
• Responsible for inspecting and providing quality review of all ARI Biospecimen shipping package contents and internal and external packaging and labeling to ensure compliance, retention of specimen integrity and adherence to all Fed-Ex and IATA regulations.
• Work together with CRCs and Technical Operations Manager to complete weekly/ monthly ARI Shipment Tracking Forms summarizing shipment details in preparation for submission to corporate accounting.
• Work with the CRCs in updating and submitting the Avaden Rainbow report as required detailing status of all active projects. Report directly to Sponsors as required regarding active project status.
• Responsible for evaluating the overall performance of ARI CRCs on an annual or as otherwise indicated basis and will work in conjunction with Human Resources and Corporate Management to help satisfy employee needs and bring resolution to any employee related issues.
• Continue to assist in the timely completion and management of Sponsored Clinical Trials.
• Complete annual training programs within the required timeframe and regularly attend staff meetings as requested.
• Maintains strictest confidentiality
• Complies with all State, Federal, professional regulations as well as company and departmental rules, polices, and procedural manuals
• Adherence to HIPAA, Safety and OSHA Regulations
• Performs other duties as assigned.

Education:

• Pathology Assistant or advanced Med-tech degree and certification preferred. BA/BS/MA/MS science related degree preferred.

Experience:

CRSPM must have a minimum of 2 years' experience as a Project Manager and have demonstrated competency in all areas of project management.

CRSPM must possess experience working with highly detailed clinical research protocols. Knowledge of hospital departmental policies and operations helpful. Experience or knowledge of histology, cytology and pathology strongly desired. Supervisory or management experience desired.

Requirements:

• Good communications and patient skills
• Familiar with Microsoft Office programs.
• Well versed in medical terminology relevant to the field of pathology.
• Ability to understand and abide by FDA Good Clinical Practice Guidelines.

Equipment:

• Must be able to have access to a vehicle.
• Must be able to travel 30% - 40%.

Knowledge/Skills/Abilities:

• Must exhibit excellent leadership skills.
• Good computer skills. Especially Excel.
• Comfortable in a laboratory and hospital pathology environment
• Compassionate and caring with respect to communicating with cancer patients.

Environmental Working Conditions:

• Laboratory Setting; Exposure to communicable diseases, toxic substances, blood borne pathogens and chemical hazards.
• Work Performed in general office environment.
• Office Setting, with some minimal time in a Laboratory Setting; minor risk of exposure to communicable diseases, toxic substances, blood borne pathogens and chemical hazards.
• Travel Required

Physical Requirements:

• Physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to stand; walk; sit; use hands to finger; handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear; taste or smell. The employee must occasionally lift and/or move up to _10__ pounds.

Specific vision abilities required by the job include close vision, distance vision, and the ability to focus.

Scheduled Weekly Hours:
40

Work Shift:

Company:
Laboratory Medicine Consultants LTD

Sonic Healthcare USA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

This job has expired.