EDUCATION:

Bachelor’s degree in science or health-related field preferred

EXPERIENCE:

Four years clinical research experience desired

REQUIREMENTS:

Clinical research certification (ACRP or SOCRA) required; Advanced Clinical Research Associate certification preferred.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Knowledge of laws, policies and procedures applicable to clinical research.
• Knowledge of, and ability to establish/maintain, a safe work environment.
• Skill in applying/modifying the principles and techniques of clinical research in a patient care setting.
• Skill in problem identification and resolution.
• Skill in preparing/maintaining detailed records, writing reports and responding to correspondence.
• Ability to maintain quality control standards.
• Ability to react calmly and effectively in all situations.
• Ability to communicate clearly

GENERAL SUMMARY OF DUTIES:

Research Coordinator coordinates and supports the clinical site in planning and executing multiple phase clinical trials, as well as evaluating and pursuing opportunities for additional trials. Initiates, monitors, completes and secures all required documents for the clinical studies and trial assignments.

ESSENTIAL FUNCTIONS:

1. Performs all study activities related to start up, active phase and the closeout. This includes:

• Recruiting and pre-screening participants;
• Collecting study data (includes the collection and handling of specimen samples, as appropriate) in accordance with established protocols; and
• Organizing/managing data in study folders/binders, whether manually and/or electronically; and
• Entering contact information in database(s), preparing study packets with appropriate regulatory checklists for review by the PI and submitting them to sponsor.

1. Serves as a liaison between Principal Investigator and sponsor. This includes:

• Participating in pre-trial assessments, initiation visits and investigator meetings;
• Communicating with study monitors and coordinating visits;
• Developing and revising study budgets that reflect standard pricing for required procedures for review by the PI and submission to the sponsor/CRO.

1. Processes all regulatory packets for submission to the sponsor. This includes:

• Obtaining patient signatures required to provide site-specific informed consent for trial participation;
• Compiling additional signatures of authorization/acknowledgement required for Clinical Trial Agreements, study protocols/amendments, completed FDA forms and updated C.V.s and medical licenses for personnel involved in the trial.
• Managing correspondence and queries to/from the IRB requesting review and approval for site and site information forms.

1. Attending IRB meetings when necessary.
2. Researching and evaluating additional study opportunities and making recommendations to the PI based on study viability and compatibility with the research program.
   Requirements: