Reports To: Clinical Research Manager
We want you on our team! We are seeking a dedicated and detail-oriented Clinical Research Coordinator. You will be part of a growing and innovative research team. The Center for Cancer and Blood Disorders has more than 60 cancer specialists and 400 health care professionals representing many different areas of medical and administrative services across 22 locations throughout North Texas.
Work-Life Balance
· Monday–Friday Day Shift
· No weekends
· Major holidays off
Competitive Benefits Package
· Competitive pay based on experience
· Medical, dental, and vision insurance
· Paid time off (PTO)
· Paid holidays
· 401(k) with company match
WORK LOCATION – Primary location is FW clinic with occasional travel to other locations
GENERAL SUMMARY OF ROLE – A Clinical Research Coordinator serves as the primary point of contact for study participants. The CRC monitors the safety and well-being of the patient and facilitates their treatment in accordance with protocols. They are responsible for recruiting and enrolling eligible participants, obtaining informed consent, collecting accurate data, and acting as the protocol Subject Matter Expert (SME).
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Responsible for identifying and screening potential patients by reviewing medical records and reports to determine eligibility
- Throughout the conduct of the clinical trial, assesses and maintains adherence to company SOPS, Good Clinical Practice (GCP), and ICH regulations and guidelines
- Maintains research records in a confidential manner according to practice policies
- Supports and collaborates with Research Team by providing accurate and timely data collection, documentation, entry, and reporting consistent with ALCOA principles
- Collaborate with clinical staff and ancillary departments for protocol training, scheduling and care for enrolled subjects, distribution of study information to appropriate parties, and acting as subject matter expert (SME)
- Serves as a point of contact for the sponsor and other entities involved in clinical research studies
- Attends and participates in departmental and investigator meetings
- Assists with preparation and creation of source document templates
- Coordinates with applicable personnel to collect and ship specimens to study central laboratories
- Prepares for and participates in audits conducted by study sponsors, federal agencies, or specially designated review groups
- Participates in site selection visits, study initiation visits, and monitoring visits
- Ensures compliance with protocol related treatments and evaluations and assisting the PI and Clinical Research Manager with designing and implementing process improvement as needed
- When needed, assists in the preparation of documents for Institutional Review Board submission including informed consent, protocol amendments, safety reports, and other regulatory activities
- Assists with preparation and creation of source document templates and department SOPs
KNOWLEDGE, SKILLS & ABILITIES:
- Experience working as a clinical coordinator or healthcare professional in a clinical setting (oncology preferred)
- Understanding of GCP and ICH regulations and guidelines preferred
- Must have professional demeanor and strong communication skills with the public as well as physicians/researchers
- Proficient in Microsoft Office software, including Word, and Excel
- Detail-oriented with working knowledge of scientific, medical, and regulatory terms preferred
- Excellent writing & communication skills
EDUCATION:
- Degree in a science discipline from a college or university with a 4-year bachelor’s preferred; OR one to two years related experience and/or training; or equivalent combination of education and experience in conducting clinical trials
- Research experience with knowledge of the conduct of clinical trials preferred but not required
- Hematology/Oncology experience is preferred but not required
- APPLICABLE CERTIFICATIONS/LICENSURE:
o Society for Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification required following 2 years of employment
o Current professional medical professional in the state of Texas if applicable
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Experience:
- clinical coordinator or healthcare professional: 1 year (Required)
Work Location: In person
