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Clinical Research Manager for Oncology Studies
2 months ago
Position Overview:
The Clinical Research Coordinator is primarily tasked with overseeing Oncology clinical trials. This role encompasses identifying potential study participants, assessing their eligibility for clinical trials, coordinating patient evaluations, managing treatment initiation and continuation, addressing clinical trial-related inquiries, completing necessary documentation with relevant departments and agencies, and maintaining accurate records for enrolled patients.
Key Responsibilities:
• Comply with Research Standard Operating Procedures (SOPs)
• Follow Good Clinical Practices and adhere to study protocols
• Coordinate all research activities for patients, providing necessary assistance, guidance, and information
• Complete and maintain case report forms in accordance with FDA guidelines, ensuring accuracy and legibility against the patient's medical records
• Collaborate closely with physicians, nurses, and other healthcare professionals to identify suitable candidates for clinical trials, assisting in the recruitment and screening process
• Ensure precise transcription of trial data
• Educate patients, families, and clinic staff about research protocols and investigational agents
• Manage all aspects of clinical trials conducted at the Cancer Institute, including entering orders in the Electronic Medical Record (EMR) for research-specific visits and procedures
• Meet with patients during each visit and remain accessible to address any questions or concerns regarding study participation
• Dispense study medications responsibly and in accordance with protocol guidelines, including patient diaries where applicable
• Collect, process, and ship blood and urine specimens during scheduled patient visits
• Conduct ECGs and administer questionnaires
• Ensure that both serious and non-serious adverse events are documented and reported in line with protocol and institutional guidelines
• Submit patient reimbursement requests to the Clinical Research Manager
• Attend Investigator Meetings and Protocol-Specific Training Webinars/Meetings
• Perform other duties as assigned
Qualifications:
• A minimum of 3 years of experience in Clinical Research, with a preference for Oncology experience
• Familiarity with clinical research practices
• Strong written and verbal communication skills, along with proficiency in computer usage, attention to detail, organizational abilities, and problem-solving skills
• Commitment to ongoing self-education and participation in scheduled meetings
• Ability to effectively present information and respond to inquiries from physicians, staff, sponsors, and patients
• Experience in interpreting medical charts and abstracting data from medical records
• Knowledge of medical terminology
• Capability to organize and coordinate multiple patients' research activities in compliance with protocol requirements
• Ability to thrive in a fast-paced, multi-demand environment
• Proficient in functioning effectively within a team setting
• Skill in prioritizing a high volume of work and meeting deadlines efficiently
HIPAA Compliance:
The Clinical Research Coordinator will have access to Protected Health Information (PHI) and electronic Protected Health Information (ePHI) during the course of their duties. This employee will adhere to the minimum necessary standard of HIPAA, accessing only the essential record sets required to perform their responsibilities.
Interpersonal Skills:
Ability to develop and maintain effective relationships with research staff, communicate effectively in both written and verbal formats, and prepare and present reports. Capability to remain calm and composed in urgent situations.
Critical Thinking Skills:
Planning and organizing abilities, along with skills in exercising initiative, judgment, problem-solving, and decision-making. Proficient in developing comprehensive reports and interpreting complex operations, with the ability to set priorities and avoid crisis management.
Physical Demands:
This position requires sitting, walking, bending, stooping, stretching, and the ability to lift or move materials weighing up to 50 lbs.
Working Environment:
Typical office environment.
Equipment Used:
Computer, printer, copier/scanner, telephone, voicemail, and fax.
