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 treatment? 
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.