Assistant Clinical Research Coordinator
Title: Assistant Clinical Research Coordinator
Location: Secaucus, NJ, onsite
Reports to: Manager of Clinical Operations.
Full-time/ Hourly
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:
The Assistant Clinical Research Coordinator Assists the Clinical Research Coordinator in developing strategies for implementing study procedures in compliance with the study protocol.
Roles & Responsibilities:
- Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures.
- Develops a strategy for implementing study procedures in compliance with the study protocol.
- Performs study procedures (e.g., obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators.
- Records study data in the source documents. Evaluates and reviews study data to ensure accuracy and completeness.
- Assists the clinic team in transcribing study data from source documents to sponsor designated electronic case report forms.
- Resolves data queries in conjunction with the sponsor.
- Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
- Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the sponsors and IRB.
- Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator.
- Maintains investigator/sponsor files in accordance with the FDA and GCP Guidelines.
- Assists in the screening of research subjects to evaluate their eligibility for a clinical study.
- Creates and performs QC procedures.
- Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators.
- Other assigned.
Education, Experience & Skills Required:
- At least 6 months’ experience supporting clinical research study conduct.
• Must possess a general knowledge of applicable clinical research regulatory requirements; general knowledge of GCP and ICH guidelines is preferred.
• Strong computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint.
• Strong written and verbal communication skills.
• Effective time management and organizational skills.
• Attention to detail and accuracy in work.
• Knowledge of applicable protocol requirements.
Salary: $25.00/hour
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
- At least 6 months' experience supporting clinical research study conduct
- General knowledge of clinical research regulatory requirements
- General knowledge of GCP and ICH guidelines
- Strong computer skills including proficiency in Microsoft Word, Excel, and PowerPoint
- Strong written and verbal communication skills
- Effective time management and organizational skills
- Attention to detail and accuracy in work
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.
