Careers
Clinical Research Coordinator
Scope
GENERAL SUMMARY OF DUTIES – Responsible for the efficiency and accuracy of out-patient clinical trial conduct with the strictest adherence to ICH, GCP, protocol, and ACMR guidelines, regulations, and policies.
REPORTS TO – Clinical Operations Manager
Duties
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Prescreening/Recruiting potential subjects for active enrolling and upcoming studies
- Utilizing medical records database for chart review
- Follow-up clinic database for chart review
- Reviewing all potential subject history and information from Intake/Marketing
- Confirming history and information with potential subject and study physician
- Refers potential subjects when appropriate for inpatient screening
- Educating potential subjects, caregivers, and referral sources on protocol specific details and expectations; work with the physician to address all medically related questions and concerns as part of the informed consent process.
- Coordinating of scheduled visits and adherence to protocol visit windows
- Performing safety and efficacy assessments per protocol
- vital signs, EKGs, draw and process blood samples
- Collaborates with the research pharmacist to perform drug accountability and compliance at each visit and educates subject on proper dosing regimen
- Accurate completion of all study related paperwork
- Completion of Source within 24 hours of subject visit
- Completion of CRFs within 48 hours of subject visit
- Prompt resolution of all study related queries
- Timely reporting of study events (SAEs, protocol deviations, etc) to appropriate regulatory and other agencies (IRBs, Sponsors, CROs)
- Follows subjects through study completion and creates follow-up care plan with physician, study subject and primary care provider
- Performing safety and efficacy assessments per protocol
- Ensuring preparation for and facilitating of all study monitoring visits
- On-going education of key staff members regarding protocol specific tools, updates, roles, responsibilities and expectations
- Maintaining professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and clinical staff members
- Assisting management in maintaining a positive and motivated work environment
- Properly managing voice mail, e-mail and exhibits proper telephone etiquette
- Assuming regularly scheduled ‘on-call’ rotation to include weekends
- Other duties as assigned
Qualifications
KNOWLEDGE, SKILLS & ABILITIES
- Demonstrated expertise in:
- knowledge and understanding of federal regulations protecting human subjects in research and that govern the conduct of clinical trials
- providing strong leadership and mentorship to others
- developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level
- crisis management and problem solving; ability to react calmly and effectively in emergent situations
- working independently as well as functioning as part of a team
- communicating clearly both written and verbally
- Highly proficient in:
- completing paperwork with precision, accuracy, and attention to detail
- meeting timelines and attention to detail
- prioritizing daily tasks with minimal guidance
- using electronic equipment (e.g., e-mail, computer, fax machine, copier, etc)
- using medical equipment and instruments to administer study subject care
- Established skill in
- basic clinical skills to obtain patient vitals (measure pulse, respiration rate, blood pressure, EKG, height and weight, draw and process blood samples)
- medical terminology
- Available to travel up to 15% of time (nationally and internationally) to include weekends
EDUCATION
- BA/BS required.
EXPERIENCE
- 2+ years experience in clinical trials
CERTIFICATE/LICENSE - CCRC preferred. CPR training provided.
