Study Coordinator / Clinical Research Coordinator

Description

Summary: Join START Center for Cancer Research as a Study Coordinator / Clinical Research Coordinator, playing a pivotal role in accelerating new cancer drug development and improving patient lives. Highlights: 1. Contribute to cutting-edge Phase I clinical oncology research. 2. Ensure data validity and compliance in clinical trials. 3. Collaborate with investigators for patient eligibility and protocol adherence. **STUDY COORDINATOR/ CLINICAL RESEARCH COORDINATOR** START Center for Cancer Research (“START”) is the world’s largest network of Phase centers, fully dedicated to clinical oncology research. Throughout our history, START has provided hope to cancer patients in communities worldwide, giving them access to cutting\-edge trials in the United States and Europe. Currently, with over 1,300 studies conducted and research centers in the United States, Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new cancer drugs that improve quality of life and survival for cancer patients and lead to eventual cures. To date, more than 43 therapies conducted at START centers have received FDA/EMA approval. Available Position: **Study Coordinator / Clinical Research Coordinator** **Responsibilities:** * Identify the requirements for Phase I clinical trials, including objectives, cohorts, and patient care needs. * Ensure the validity of the data obtained in the source documents. * Provide all necessary information and documentation about the clinical trial from its implementation and any subsequent amendments to the rest of the research team. * Attend meetings regarding assigned studies as needed, including SIV’s, MOV’s, COV’s, Roster meetings and Forms Committee. Be available and on site for monitor’s meeting during MOVs for assigned studies. * Prepare and attend internal and external audits for assigned studies. Be available and on\-site, if required, during audits for assigned studies. * Complete all necessary training to initiate the clinical trial at the Unit. * Inform the patient about the procedures and side effects related to the clinical trial and the investigational drug(s) – Patient education. * Ensure that the informed consent process complies with CEIC, GCP, sponsor, and EC guidelines. * Collaborate with the Investigator to determine a patient’s eligibility to participate in a clinical trial, including the necessary documentation regarding the inclusion/ exclusion criteria specified in the protocol. * Ensure compliance with the protocol schedule regarding procedures, events and requirements for each visit. * Conduct follow\-up/safety/survival calls to patients in accordance with the protocol, once the patient has completed treatment in the trial, during the period required by the protocol. * Ensure data timepoints are accurate and provide query resolution. * Guarantee that data transmission remains up to date for the assigned studies. * Maintain internal data tracking systems regarding slots’ availabilities and patient’s waiting list. * Entering data into the billing system and being responsible for its accuracy. * Maintain the Patient Files (binders \& electronic) and ensure that all data is accurate and up to date. * Share responsibility with Data Managers to identify lab facilities and normal lab values used for assigned studies, so that lab certifications can be requested for the study file. **Requirements:** * Nursing degree * Keen sense of responsibility and attention to detail * Ability to work in a team and maintain effective communication with colleagues and supervisors. * Intermediate level of English * Basic understanding of oncology clinical trials, particularly Phase 1 studies. * Great attention to detail and meticulousness in data collection and documentation. * Ability to manage multiple tasks and meet deadlines in a challenging environment. * Excellent organizational and time\-management skills. * Effective communication skills, both written and verbal. * Ability to interact professionally with patients, study staff, and external stakeholders. * Working knowledge of GCP and regulatory requirements. * Proficient in Microsoft Office Suite and clinical trial management software. **Are you ready to be part of a team that will change the future of cancer treatmen**t? Join us in our mission to defeat cancer, one clinical trial at a time. Your experience and dedication can help us bring hope and healing to patients around the world. **Submit your application online.**