Clinical Research Coordinator

Clinical Research Coordinator

Title:Clinical Research Coordinator

Location: Frontage Clinical Services, Inc. in Secaucus, NJ

Reports to: Manager of Clinical Operations

Full-time

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary:

Responsible for working under the guidance of the Principal Investigator and Sub-Investigators, and Clinic Operations to participate in the planning, implementation and overall direction of Clinical Research trials conducted on behalf of sponsors at the Frontage Clinical Services, Inc. The Clinical Research Coordinator is required to perform study procedures, to generate, evaluate, review and record study data, to transcribe source data to case report forms, to liaise with sponsor personnel, to maintain a high level of professional expertise through familiarity with the study protocol, investigator's brochure, and related study materials, and to participate in project team meetings. The Clinical Research Coordinator II assists the Principal Investigator in conducting Clinical Research studies in compliance with applicable regulations and GCP guidelines.

Roles & Responsibilities:

• Oversees study conduct for the assigned clinical trials.
• Assists with the preparation of protocols, informed consents, protocol amendments and other necessary documents for review by the sponsors and IRB. Actively participate in any sponsor or FDA audit.
• Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator.
• Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators.
• Maintains investigator/sponsor files in accordance with the FDA and GCP Guidelines.
• Participates in internal/external client meetings
• Develops a high level of knowledge of the study protocol and flow chart of study procedures.
• Performs study procedures (e.g., start intravenous lines, venipunctures, obtain biological specimen samples, processes specimen, obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol.
• Develops a strategy for implementing study procedures in compliance with the study protocol. Resolves data queries in conjunction with the sponsor.
• Assists Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
• Send daily study updates to project managers.
• Actively involved in recruitment and in the screening activities of research subjects to evaluate their eligibility for a Clinical Research study.

Education, Experience & Skills Required:

• BS or MS in biology, chemistry, or related area would be preferred.
• A minimum of 1 year experience in Clinical Research is desirable.
• Solid knowledge of Good Clinical Practices and FDA regulatory requirements.
• Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Research personnel and sponsor personnel.
• Excellent organization and planning skills.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.