The Clinical Research Coordinator Research Study Coordinator/Study Coordinator 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. They are responsible for implementation as well as completion of protocol specific requirements and will provide accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements. They will assist in the maintenance of all study related Case Report Forms, whether paper or electronic as well as know status of completion. They will understand the ethical issues involved in human subjects research, adhering to the Federal Regulations governing research.

Essential Responsibilities:

Will be courteous and professional in both written and oral communication, expressing as well as communicating ideas in a non-confrontational manner in one-on-one situations, small groups, larger audiences, email communication, etc...

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

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

Other duties as assigned

Required Skills & Abilities:

Demonstrates an ability to work independently in a self-directed environment

Effective time management and organizational skills

Effective written and verbal communication skills

Working knowledge of a variety of health care equipment

Ability to make quality, independent decisions

Ability to instruct and direct the work of others

Able to work effectively and efficiently under tight deadlines, high volumes, and multiple interruptions

Education & Experience:

Minimum of 2 years of patient and/or clinical team member experience, oncology preferred

Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC credentials is highly desirable

Physical Requirements & Work Environment

Approximately 80% of time is spent sitting

Very fast-paced and ever-changing healthcare environment

Demanding deadlines and time frames

Constant demand for updating knowledge

Works closely with physicians and ancillary personnel in caring for and treating oncology/hematology patients