Clinical Research Coordinator, Denver, CO

Advanced Dermatology • Denver, CO

366d • $24 - $30

About The Position

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Requirements

• Bachelor's degree in a related field preferred but not required.
• Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) Certification from SoCRA or ACRP.
• Good Clinical Practice (GCP) preferred.
• International Air Transport Association (IATA) Training preferred.
• Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards.
• Ability to practice confidentiality and follow HIPAA regulations with patient information.
• Knowledge of medical terminology and ability to use appropriately.
• Ability to manage time efficiently, prioritize, multi-task, and adapt to change.
• Ability to maintain high level of accuracy in all documentation and in the performance of all job duties.
• Skilled in typing/keyboarding; skilled in using computers.

Responsibilities

• Coordinates with Principal Investigator, department, and administration to help ensure that clinical research and related activities are performed in accordance with Federal Regulations and sponsoring agency (pharmaceutical and or CRO) policies and procedures.
• Assists the PI in study feasibility assessments as requested.
• Reviews and comprehends the protocol.
• Attends investigator meetings as required or requested by the PI.
• Collaborates with the PI to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.
• Prepares other study materials as requested by the PI.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assists PI in communication of study requirements to all individuals involved in the study.
• Collects documents needed to initiate the study and submit to the sponsor.
• Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the (IRB) and discussions with research participants.
• Develop advertising and other informational materials to be used in subject recruitment.
• Identifies and calls possible subjects for recruitment, schedules appointments for study visits, maintains enrollment logs and sends them to study sponsor or CRO.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria.
• Coordinates participant tests and procedures, draws blood or collects urine sample for laboratory testing as specified by the protocol.
• Collects data and performs assessments specified in the protocol.
• Maintains study timelines.
• Maintains adequate inventory of study supplies.
• Completes study documentation and maintains study files in accordance with sponsor requirements.
• Tracks enrollment status of subjects and document dropout information.
• Retains all study records in accordance with sponsor requirements in Regulatory binder.
• Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies.
• Arranges secure storage of study documents that will be maintained according to the contracted length of time.

Benefits

• 401K
• PTO
• Vacation
• Benefit Packages

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees