Research Operations Manager
Sonic Healthcare USA

Job Info

---

Job Functions, Duties, Responsibilities and Position Qualifications:

Job Summary:

The Clinical Research Specialty Operations Manager (CRSOM) will be responsible and accountable for the successful completion of all contracted prospective collection projects. Projects include those based at ARI affiliated institutions and laboratories as well as non-ARI affiliated institutions, laboratories and physician specialty practices. Biospecimen collections include but are not limited to fresh tissue, blood, bone marrow, other fluids and all associated data. The CRSOM will work in tandem with multiple Principal Investigators, CRCs and the Clinical Research Project Manager to oversee project fulfillment progress by managing day to day local and remote prospective collection activities and operations. In addition, the CRSOM will also be responsible for managing collective site responses to client study related inquiries as other client or project related issues relevant to specialty collections.

Essential Key Responsibilities:

• Upon commencement of job, the CRSOM is responsible for successfully completing the "Protecting Human Research Participants" course provided by the NIH Office of Extramural Research or its equivalent.
• Become familiar with all active and proposed prospective collection study specifications and criteria associated with each and every relevant ARI Study. Prior to initiation of study, assist in introducing the studies to any and all assigned CRCs (local and / or remote) and making sure that all Study requirements, specifications and timelines are understood.
• Work with all approved collection sites to document accrual rates and respond to all inquiries relevant to collection capabilities and timing.
• Personally participate in active prospective collections and all related peripheral activities as necessary to ensure successful timely completions in accordance with established deadlines.
• Work together with the Clinical Research Project Manager in providing updates and input relevant to all active prospective studies. Participate in all relevant ARI team meetings and conference calls relevant to project status, progress and direction.
• Work with the Clinical Research Project Manager in assisting with complex specialty project requests that require special skills above and beyond those required to fulfill routine study requests, (i.e. Studies requiring extensive Treatment and Outcome data).
• Work with Study Sponsors when appropriate to communicate all related collection activities and issues impacting the Study.
• Coordinate training for new prospective collection sites resulting in successful operationalizing all study protocols. Work with CRCs involved in the consenting process to ensure that study objectives are communicated in an effective and compassionate way to the Study Subjects.
• Assist in the engineering of institution specific mechanisms necessary to search, identify and intersect with Study Subjects to determine participation potential for active studies.
• Accumulate data regarding successful vs non-successful collections and patient consenting and make recommendations when necessary and appropriate.
• Manage the documentation of corresponding data submitted by the all prospective collection sites. Enter progress into the ARI 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 collection Studies over multiple Institution and practice locations and travel to study locations as required and as necessary to assist in the training, implementation and monitoring of all Study protocols.
• Assist in the training and on-boarding of new (ARI and non-ARI) CRCs involved in prospective collections. 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.
• Assist 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 related 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.
• Coordinate all prospective collection shipments to a central biorepository or direct to sponsor as indicated in the project work orders. 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 with Clinical Research Project Manager to complete weekly/ monthly ARI Shipment Tracking Forms summarizing prospective collection shipment details in preparation for submission to corporate accounting.
• As a member of the ARI Management Team accept project assignments and assist on project assignments as necessary to help facilitate achievement of ARI Goals.
• 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:

• Nursing or Med-tech degree and certification desired. BA/BS science related degree preferred.

Experience:

Experience working with highly detailed clinical research protocols and the informed consenting process desired. 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:
Greensboro Pathology LLC

Sonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This job has expired.