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.
Salary: $50K - $52K annual salary
Benefits:
• 401k Employer Match with immediate vesting
• Vision Insurance
• Medical and Dental Insurance with multiple coverage options
• FSA (Medical, Dependent Care, and Commuter)
• Short Term Disability
• Long Term Disability
• Life Insurance
• 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.
Skills Required
- BS or MS in biology, chemistry, or related area
- Minimum of 1 year experience in clinical research
- Solid knowledge of Good Clinical Practice (GCP) and FDA regulatory requirements
- Ability to perform clinical procedures (start IV lines, venipuncture, obtain/process biological specimens, obtain ECGs, vital signs)
- Excellent communication skills to interact with investigators, sponsors, and clinical staff
- Excellent organization and planning skills
- Familiarity with study protocols, informed consent administration, and maintaining regulatory/investigator files
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
