Clinical Research Nurse Coordinator I in Midland, Texas at ERA Health Research

DUTIES & RESPONSIBILITIES

Responsibilities:

• Identify objectives, endpoints and outcome measures for a given clinical trial.
• Implement protocol and any protocol amendments according to GCP, verifying that only IRB/IEC approved versions of study documents are being used.
• Schedule, coordinate, and prepare documents, equipment, facilities for site initiation visits.
• Complete training and interpret a study implementation plan for relevant items that impact the tasks and activities the coordinator should prioritize for a given trial.
• Ensure consistency between the sites’ standard operating procedures (SOPs) and the study requirements.
• Identify all study supplies needed for a given clinical trial, assess and reconcile inventory to ensure adequate supplies throughout the trial.
• Develop and organize trial management tools such as subject study calendar, source documents, and retention materials to enhance subject compliance.
• Complete pre-screening, screening and enrolment logs and forms in an accurate and timely manner.
• Coordinate with regulatory, recruitment, and clinical staff to schedule patient visits
• Complete informed consent and randomization of subjects accurately and according to the protocol and SOPs to ensure appropriate inclusion of subjects
• Support and manage investigational product, including labeling, preparing and dispensing.
• Perform nursing assessments and conduct protocol-related procedures (vitals, ECGs, IV starts, infusions, pharmacokinetic sampling, etc.).
• Administer investigational products (drugs, devices, biologics) per protocol, monitor patient responses, and provide clinical care as appropriate.
• Assess, document, and report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the PI and sponsor.
• Manage, educate and communicate with subjects throughout the trial, including providing patient education and communicating about compliance with the visit schedule, protocol procedures, diary completion, and discontinuation.
• Complete study communications, comments, and logs in an accurate and timely manner, including basic clinical data entry into Electronic Data Capture (EDC) systems, and documenting and reporting any unanticipated problems, deviations and/or safety related issues following GCP.
• Schedule, coordinate, and prepare documents for monitoring visits; review monitoring visit follow-up reports / letters and perform requested post-visit activities, including resolving queries in an accurate and timely manner.
• Collect, ship, and store specimens according to requirements.
• Help with the preparation, organization, and maintenance of regulatory documents and study binders.
• Train new team members on clinical research skills to enhance competency.
• Travel to and from other company sites as needed to perform job responsibilities.
• In addition to the specific responsibilities outlined above, this role may perform other tasks or projects as assigned by a supervisor or manager. These additional duties will fall within the scope of the role and contribute to the overall success of the team.

• Active, unrestricted Texas State Registered Nurse (RN) license required upon hire and must be maintained throughout employment.
• At least one year clinical and/or clinical research experience
• Current CPR or Basic Life Support (BLS) certification, or the ability to obtain certification within the first 90 days of employment. Employees are responsible for obtaining and maintaining current CPR/BLS certification throughout employment
• Venipuncture and IV start skills or ability to learn within first 30 days
• Meticulous attention to detail, with ability to follow complex instructions and protocols precisely
• Strong organizational and problem-solving skills
• Team player able to effectively self-reflect, communicate, and collaborate across teams
• Good written and verbal communication skills
• Proficient with basic computer software (MS Office)