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Form of workStudy Coordinator (START MIDWEST)
General Summary
Is assigned multiple protocols at any time for which they will oversee the aspects of assigned protocols with planning and coordinating patient participation in the trial.
Is responsible for implementation as well as completion of protocol specific requirements. Will provide accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements.
Will assist in the maintenance of all study related Case Report Forms, whether paper or electronic as well as know status of completion. Will understand the ethical issues involved in human subjects research, adhering to the Federal Regulations governing research.
Communicates on a regular basis with Study Sponsor’s, CRO’s, staff, etc. regarding questions, concerns, as well as status of the protocol. Will have regular communication with each CRA involved with assigned protocols.
Job Requirements
Education: Bachelor degree or equivalent.
Experience: Prior experience in clinical trials coordination
Other: Knowledge and training in general office administration skills, including computer applications, filing systems, etc. Demonstrated ability to accurately and efficiently complete assignments in Clinical Investigations and demonstrated capability to perform the data review and CRF completion in its entirety with minimal direction.
Preferred Knowledge/Skills/Abilities/Education/Experience
Bachelor degree in life sciences. Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC credentials is highly desirable. Familiarity with medical terminology desirable.
Excellent written and verbal communication skills. Ability to review detailed data and make prompt judgments based on that data. Ability to work efficiently under tight deadlines, interruptions and high work volume. Professional appearance. Able to multi-task efficiently.
Primary Duties and Responsibilities (Essential Functions)
- Will monitor the overall day-to-day conduct of assigned studies in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.
- Reviews forms created or revised for assigned trials to assure protocol compliance
- Maintains files using standardized study document labeling and filing procedures
- Implements initial protocol and amendments, training staff who will be involved in patient treatment and management
- Maintains an up to date contact list
- Assists with patient screening and determination of eligibility
- Facilitates the informed consent process ensuring that consent is appropriately completed.
- Prepares and manages source documents according to standard operating procedures
- Will recognize deviations to the protocol and will work with management and staff to address corrective actions to prevent deviations
- Will assist CRA with case report form completion and query resolution.
- Will work with the Principal Investigator to complete and submit Serious Adverse Event reports.
- Is responsible for all protocol specific closeout related activities in conjunction with the CRA.
- Will provide documentation for all deviations whether related to the protocol or a SOP.
- Will ensure that all team members involved understand and adhere to assigned protocols.
- Will also be responsible for any other duties to which they are assigned.
Function as a team member by expanding his/her responsibilities as directed by management to facilitate optimal workflow within the cancer center.
Communicates and interacts with peers and other departments in a manner that is viewed as having a positive effect on patient services and CHCWM staff morale. Interacts effectively with patients/family members and demonstrates sensitivity in regards to cultural diversity, age specific needs and confidentiality.
These functions are intended to describe the general nature, level and requirements of work being performed within this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. The listed duties may be changed at the discretion of management.
This employee has access to medical records daily. The parts of the medical record s/he needs to references to perform his/her job are as follows: Lab Information System, Pharmacy Information System, Entire Chart/Electronic Medical Record (EMR), Electronic Billing System (EBS).
Work Environment
Able to see clearly in an environment which is equipped with typical lighting. Able to perform manual tasks that require the use of fine muscle motor skills. Able to walk approximately one mile per workday. Able to lift 20 pounds. Able to stand and / or sit for prolonged periods. Able to freely bend/stretch. Able to access, input and retrieve information from computer. Able to tolerate frequent handwashing. Very fast-paced and ever changing office environment. Demanding regarding deadlines and time frames. Very detailed and challenging work. Constant demand for updating knowledge.
