Lead Clinical Research Coordinator - Crc

Summary

Direct patient care and maintenance of the appropriate documentation, which is regulated by the FDA and Pharmaceutical companies. Works with PI and PA, but functions independently; responsible for training, supervising and coordinating assignments for Clinical Research staff.

Responsibilities

· Conducts study start-up activities and prepares and maintains regulatory documents required by sponsor and/or regulatory agencies.

· Identifies and recruits eligible study subjects; conducts informed consent/assent process.

· Arranges and conducts Clinical Research visits.

· Conducts site qualifications, study initiation, monitoring and/or close-out visits.

· Attends investigator meetings as needed.

· Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms.

· Creates and/or updates case report forms and/or source document templates.

· Coordinates reimbursement of subjects.

· Maintains inventory of supplies/equipment.

· Prepares lab kits and requisitions prior to visits.

· Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly.

· Records data on source documents and CRF's and/or electronic web based systems.

· Conducts literature searches and assists with QA/QC procedures.

· Monitors/assesses adverse events and reports them as required.

· Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.).

· Functions as patient liaison for study questions.

· Maintains all study documents (regulatory binders, source documents, correspondence, etc.).

· Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences (planning, presenting, etc.) as needed.

· Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients.

· QA/QC checks for database validity and data monitoring.

· Coordinates multiple and/or more complex Clinical Research protocols.

· Assists in the training of personnel for role in study conduct; maintains delegation of authority and training logs.

· Verities participant eligibility.

· Evaluates new protocols for feasibility.

· Assists with site visits and responds to sponsor queries/requests promptly.

· Participates in evaluation and process improvement for Clinical Research studies and/or processes.

· Establishing and maintaining processes to ensure smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure.

· Functions as a mentor to the research staff.

· Maintaining a high level of knowledge and understanding of any number of assigned protocols for varying therapeutics and applicable local and federal regulations governing clinical trials with humans as subjects.

· Assuring well-being and rights of research subjects, integrity and quality of research data collected.

· Assists investigators with submission of required documents to regulatory authorities (e.g. FDA) when applicable.

· Trains and supervises daily activities of research staff.

· Develops systems for assuring protocol adherence and data quality.

· Leads activities designed to improve organizational performance.

· Leads any audit preparation and responds to any audit findings with PI/PA.

· Develops division/department SOPs consistent with best practices to enhance the ethical conduct of research if/when needed.

· Assists with onboarding of new staff.

· Ensuring participant recruitment, pre-screening, screening, enrollment and retention.

· Conducting participant study visits, including obtaining informed consent, obtaining medical histories, recording reported adverse events and concomitant medications and taking vital signs, recording ECGs, performing phlebotomy and processing and shipping labs.

· Interacting with Principal Investigator(s) as needed to assure participants receive appropriate medical evaluations and care when needed.

· Assisting with fulfilling regulatory reporting requirement to the IRB, Sponsor and/or FDA.

· Abstracting data from medical records and other sources for entry into, and completion of, all study documentation forms, including case report forms (electronic and paper) and other study specific documents.

· Interacting with sponsor representatives (CRAs) to facilitate the sponsor monitoring and database clean-up process.

· Attending sponsor Investigator/Study Coordinator meetings as needed for assigned protocols.

· Experience training multi-disciplinary staff or teams, preferred.

· Other duties as necessary to manage the timely implementation of a clinical trial.

Qualifications

· BA/BS in health sciences with at least 5 years Clinical Research experience.

· LPN/CMA with at least 7 years Clinical Research experience may be substituted for BA/BS requirement.

· Will consider 10 years verifiable experience in leu of a bachelor's degree.

· Prior Leadership experience preferred.

· Strong experience taking vital signs, performing phlebotomy (required), recording ECGs, processing and shipping labs.

· Strong background in medical history intake, including familiarity with medical terminology.

· Ability to work independently, as well as with co-workers, peers, monitors and potential subjects.

· Ability to multi-task while maintaining a strong attention to detail.

· A ‘can do’ attitude, professional drive and motivation.

· Knowledge of local and federal regulations governing clinical trials with humans as subjects.

Competitive Salary