Clinical Research Coordinator

Metaintro, Inc.; Secaucus (NJ); Hybrid; USD 50,000 - 52,000; Full time

Benefits offered by this job

401k Employer Match with immediatevest

Medical and Dental Insurance

FSA (Medical, Dependent Care, and Com-

Generous Paid Holidays and PTO

Job summary

Frontage Laboratories Inc. is seeking a Clinical Research Coordinator in Secaucus, NJ, to support planning, implementation and direction of clinical trials.

You will perform study procedures, transcribe data to case report forms, liaise with sponsor personnel, and maintain protocol familiarity under supervision. Ideal candidates hold a BS/MS in biology/chemistry, have 1+ year clinical research experience, and demonstrate strong communication and organizational skills in a regulated environment.

Qualifications

• BS or MS in biology, chemistry, or related area preferred.
• Minimum 1 year of clinical research experience desirable.
• Solid knowledge of Good Clinical Practices and FDA regulatory requirements.
• Strong communication skills with PI, sub-investigators and sponsor personnel.
• Excellent organization and planning abilities.

Responsibilities

• Oversees study conduct for assigned clinical trials.
• Assists with protocol/informed consent documents and sponsor/IRB reviews.
• Administers informed consent under PI supervision.
• Maintains source documentation and investigator/sponsor files.
• Participates in meetings with internal and external clients.
• Gathers and records data, resolves data queries with sponsor.

Skills

Communication skills

Organization

Planning skills

Education

BS or MS in biology or chemistry

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Research Coordinator

Full Time Secaucus, NJ, US

30+ days ago Requisition ID: 1841

Salary Range: $50,000.00 To $52,000.00 Annually

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.

• 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.
• 401k Employer Match with immediate vesting
• Medical and Dental Insurance with multiple coverage options
• FSA (Medical, Dependent Care, and Commuter)
• Generous Paid Holidays and PTO

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.