Regional Travel, Clinical Research Coordinator

Care Access•Aurora, CO

2h•$75,000 - $105,000•Onsite

About The Position

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. This role makes a difference by coordinating patient care, maintaining adherence to regulations, and fostering positive relationships with participants and staff. The role involves moderate complexity with mixed visit types, active IP and AE/SAE workflows, and the ability to operate as a solo CRC onsite. Key tasks include prescreening candidates, obtaining informed consent, completing visit procedures and basic clinical procedures, and reviewing test results. Documentation is crucial, including real-time data entry, accurate recording of study medication, and resolving data management queries. Patient recruitment assistance, including planning and developing recruitment materials and actively working with the recruitment team, is also a responsibility. Other duties include reviewing protocols, ensuring training requirements are met, clear communication, anticipating needs, attending investigator meetings, owning studies, and ensuring adequate supplies for trial initiation.

Requirements

Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology.
Excellent working knowledge of federal regulations, good clinical practices (GCP).
Operates independently for most study activities; escalates complex issues as needed.
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail.
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver.
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy.
Excellent professional writing and communication skills.
Manages stakeholder communications; facilitates visits and meetings.
Ability to work independently in a fast-paced environment with minimal supervision.
Minimum of 3 years prior Clinical Research Coordinator experience required.
Recent phlebotomy experience required.

Nice To Haves

Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
1 year of experience as a Care Access Research Clinical Research Coordinator.

Responsibilities

Utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
Prioritize activities with specific regard to protocol timelines.
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Maintain effective relationships with study participants and other Care Access Research personnel.
Balance protocol needs with patient experience; proactively address concerns.
Monitor quality metrics; prevent deviations; resolve queries quickly.
Interact in a positive, professional manner with patients, representatives, investigators and Care Access Research personnel and management.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Mentor CRC I peers; provide onboarding and day-to-day guidance.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate).
Prescreen study candidates.
Obtain informed consent per Care Access Research SOP.
Complete visit procedures in accordance with protocol.
Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Record data legibly and enter in real time on paper or e-source documents.
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines.
Assist regulatory personnel with completion and filing of regulatory documents.
Assist in the creation and review of source documents.
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects.
Review and assess protocol (including amendments) for clarity, logistical feasibility.
Ensure that all training and study requirements are met prior to trial conduct.
Communicate clearly verbally and in writing.
Anticipate needs; propose solutions; manage change effectively.
Attend Investigator meetings as required.
Own studies; prioritize competing demands; mentor CRC I.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).