Oncology Research Program and Regulatory Coordinator
Lancaster General Hospital
9043 Oncology Research
Oncology Data Management
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POSITION SUMMARY: To organize, coordinate and submit materials to comply with local, state and federal regulations related to conducting oncology clinical trials in human subjects. Assist with the development and maintenance of the financial module management of clinical trials including the association of study milestones to study budget to confirm accuracy of invoicing and payment from study sponsors.
This position is 32 hours/week and located at the Ann B. Barshinger Cancer Institute. No weekends. No Holidays. Day shift. Hours between 7am-4:30pm depending on department needs.
ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:
- Prepare and process all regulatory documentation through all applicable review committees (such as IRB) including new submissions, continuing reviews, amendments, adverse events and reportable events all research protocols.
- Coordinate and participate in clinical trials required activities
- Responsible for knowing, tracking, and maintaining sponsor/cooperative group updates and regulatory requirements
- Responsible to assure correct version of consent and protocol are implemented.
- Maintain all regulatory documents for each investigator including current RCR, CITI, CV’s and medical license numbers.
- Assist with development of the financial module for clinical trials management
- Monitor and track study milestone completion and associate completion to study budget calendar for timely invoicing
- Maintain payment records from sponsor and corporate groups
SECONDARY FUNCTIONS: The following duties are considered secondary to the primary duties listed above:
- Provide program support for all team members
- Assist in development of tracking systems and report monthly
- Order supplies for unit including study lab kits
- Participate in monthly, multidisciplinary research team meeting and weekly department huddles.
- Attend conferences to maintain education on changes in federal and state regulations regarding human subjects and IRBs.
- Support of other study needs including IT ticket submissions for EMR builds and pharmacy data support as needed
- Assist with development and maintenance of Clinical Trials Management System
- Other duties as assigned.
MINIMUM REQUIRED QUALIFICATIONS:
- Associate’s decree or equivalent job related experience.
- Previous health care or related field experience.
- Strong attention to detail, organizational and multitasking skills.
- A health care provider in good standing with Medicare, Medicaid, and other federal and state health insurance programs, i.e. not excluded from participation in Medicare, Medicaid or any other federal or state health insurance program.
- Bachelor’s degree in a related field.
- Previous experience in research and/or regulatory.
ATTENTION/CONCENTRATION – The following level of ability is essential for the jobholder to focus on certain aspects of current experience and reject others:
- The position requires the ability to attend to more than one aspect of a situation simultaneously. It is highly likely that multiple task demands are going to be required of the individual at the same time.
NEW LEARNING AND MEMORY – The following level of ability is essential for the jobholder to learn and retain material:
- The position requires that an individual be able to learn new tasks quickly and effectively. Job requirements change frequently. The ability to understand and carry out detailed, involved instructions in mandatory.
PROBLEM SOLVING, REASONING AND CREATIVE THINKING – The following level of ability that is essential for the jobholder to think (in order to solve a problem) by combining two or more elements from past experience or imaginative thought:
- The position deals with issues or problems that often require thoughtful reasoning before arriving at approaches or solutions. Some independent thought, planning or origination of options and solutions is necessary. The individual must have the ability to apply principles of reasoning and problem solving to resolve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
APTITUDES: The following are essential requirements of the position in relation to job-worker situations. These items describe how a worker must adapt, adjust, conform or act:
Variety and change: Ability to perform a variety of duties, often changing from one task to another of a different nature without loss of efficiency or composure involving significant differences in technologies, techniques, procedures, environmental factors, physical demands, or work situations.
Communication: Ability to exchange information with others clearly and concisely; to present ideas, facts and technical information.
Interpersonal relations: Ability to maintain relationships that facilitate task accomplishment; to cooperate and resolve conflicts; to recognize needs and be sensitive of others.
EQUIPMENT USAGE REQUIREMENTS
Equipment/Tools: Computer, Phone, Copier, Printer, Fax, Office Supplies
Software: Microsoft Office Products
Rarely 0-10%; Occasionally 11-35%; Frequently 36-70%; Continuously 71-100%
- Sit: Continuously
- Stand: Frequently
- Walk: Frequently
- Bend: Rarely
- Push: Rarely
- Pull: Rarely
- Kneel/Squat: Rarely
- Reach: Rarely
- Twist: Rarely
- Balance: Rarely
- Climb: Rarely
Lifting: Degree of physical exertion is:
Moderate, exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Sensory Abilities specifically required:
WORKING CONDITIONS: Exposure to hazardous conditions/ materials is negligible.
Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The percentages of time spent performing job duties are estimates, and should not be considered absolute. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. Incumbent must be able to perform all job functions safely.
Posted on 07/06/2020