Clinical Research Coordinator

Clinical Research Coordinator Frontage Laboratories - 2.7 Secaucus, NJ Job Details Full-time $50,000 - $52,000 a year 1 hour ago Benefits Paid holidays Disability insurance Health insurance Dental insurance Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Qualifications Biology Vascular access Clinical study protocols and reports Vital signs Clinical research Adverse event reporting Bachelor of Science Scientific research Filing Mid-level Master's degree in biology ECG equipment Bachelor's degree in biology Transcription IV insertion Collecting samples for laboratory testing Bachelor's degree Scientific protocols Master of Science Organizational skills Chemistry Patient recruitment Research regulatory compliance IRB compliance Regulatory audits Communication skills Bachelor's degree in chemistry FDA regulations

Full Job Description 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.