Clinical Research Coordinator (Oncology)
- Reports to the Clinical Research Manager
- Plan and coordinate the initiation of assigned IRB approved clinical trial protocols; following all federal/local requirements, ICH/GCP, OSHA, IATA requirements.
- Responsible for screening, consenting, and enrolling eligible patients, as well as following all enrolled study patients to study completion; conduct study visits per protocol, and collect, process, and ship all lab specimens as required and as per IATA training and certification.
- Responsible for providing SC Investigators with information about the protocol, protocol amendments, Investigator's Brochure, ICH/GCP guidelines, and other study-required training to ensure compliance with all applicable regulations and study-specific guidelines.
- Maintain adequate and accurate source documentation in each of the study patient's medical records regarding their participation in the clinical study; accurately enter data into the sponsor's case report forms per the sponsor's guidelines; maintain accurate investigational product accountability documentation regarding the receipt, disposition, dispensation, return and destruction.
- Monitor research patients for suspected adverse events and report serious adverse events (SAEs) and any protocol deviations to the study sponsor within the appropriate time frame; provide pertinent information for submission to the proper authorities.
- Schedule and meet with the study monitors/Clinical Research Associates (CRAs) to:
- Review data entry against source documentation and assist in resolving all discrepancies, including resolving data queries.
- Liaise between the study monitor, clinic staff, and the SC Investigators to ensure that quality research is being conducted according to the IRB approved protocol, amendments, procedures, laws, and regulations.
- Assist management team in the training and mentoring of new/ lesser experienced staff.
- As needed, obtain and maintain Allied Health Professional appointments at the local hospitals.
- Comply with the Springfield Clinic incident reporting policy and procedures.
- Provide excellent customer service and adhere to SC Code of Conduct and Ethics Standards.
- Perform other job duties as assigned.
- Minimum of a Bachelor's degree in a related field.
- Clinical Research experience strongly preferred.
- CPR certification per American Heart Association guidelines required within 30 days of hire.
- It is strongly recommended that research certification (CCRP or CCRC) is obtained after two (2) years of employment and then subsequently maintained in good standing.
- A strong working knowledge of computer software including Microsoft Office, Electronic Medical Record(s), other SC platforms, and Sponsor required systems.
- Attention to detail and ability to follow and interpret approved clinical protocols is required.
- A strong working knowledge of GCP, ICH, CFR, and HIPAA laws and regulations will be required.
- Knowledge of Springfield Clinic policies and procedures.
- Ability to demonstrate good organizational skills, excellent oral & written communication skills, and excellent interpersonal skills in working effectively with Co-workers; Managers; Directors; Administration; Providers; Staff; Sponsors and Patients.
- Ability to recognize, evaluate and solve problems.
- Ability to manage projects in a team environment.
- Ability to function and perform daily work independently; perform duties and tasks assigned and follow through to completion.
- Must have the ability to control emotions and maintain composure under stress, using tact and good judgment.
- Must be able to stand and walk for long periods and capable of stooping, bending, and lifting.
- Office based with travel to other Springfield Clinic locations (including satellite offices) and other business related travel, as required to conduct day to day business aspects of the department.
- HIPAA1
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