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Clinical Research Coordinator

System One
Secaucus, NJ
  • Expired: November 03, 2021. Applications are no longer accepted.

Job Title: Clinical Coordinator

Must haves:

- At least 1 year at a phase 1 facility (CRO experience is preferred) - Able to work in a fast paced environment - GCP experience/knowledge

- Communication skills; will be interacting with client - Computer savvy (electronic source documentation is used daily)

Vaccination Mandate: "We do have a mandate, so please ask if they are vaccinated, or planning to be fully vaccinated soon. We are not accepting religious exemptions, medical we are, but doctor documentation would be required for that. We don't need the cards now, but would need them the week prior to them joining"

COMPANY INFO: Company is owned by Frontage Labs - 75 employees, functions separately but shares an infrastructure AND website. Most of the employees do not even know it's two different companies

Educational requirement: Bachelor's degree, preferably in a scientific discipline or equivalent experience

Years of experience: 1+ years Location: 200 Meadowlands Pkwy, Secaucus, NJ 07094 Type: Direct Quantity of positions: 2 Salary: $55-75K Fee: 20% Has this position been approved by finance? Yes

Describe the current team size? AD oversees coordinators, there were 3 experienced coordinators - 1 left awhile ago, other gave notice which opens why there are 2 needs today.

They hired coordinator assistants who are very junior - one was a coordinator at a doctor's office - clinical research in those settings is very slow and responsibilities were very narrow

Who should resumes be sent to? Lisa and Kelly CC'd

Client's JD:

Position title: Clinical R esearch C oordinator

Reports to: Associate Director, Clinical Operations

Duties: Planning and implementation of clinical research trials conducted on behalf of sponsors at our client. Perform study procedures, generate, evaluate, review and record study data, liaise with our client and sponsor personnel, maintain a high level of familiarity with the study protocol and related study materials, and participate in project team meetings. The Clinical Research Coordinator assists the Principal Investigator in conducting clinical research studies in compliance with applicable regulations and GCP guidelines.

Supervises: Assistant Study Coordinators, Laboratory Technicians, and Medical Assistants

Qualifications: Requires a bachelor's degree, preferably in a scientific discipline or equivalent experience.

Experience: A minimum of 1 year of experience as a Clinical Research Coordinator or a minimum of 2 years of relevant clinical research experience, thorough knowledge of FDA regulatory requirements and Good Clinical Practices.

Specific 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.

+ Submit documents to regulatory authorities.

+ 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.

+ Actively involved in recruitment and in the screening activities of research subjects to evaluate their eligibility for a clinical research study.

+ Actively participate in any sponsor audit or FDA inspection.

+ Develops a high level of knowledge of the study protocol and flow chart of study procedures. Develops a strategy for implementing study procedures in compliance with the study protocol.

+ Understands and follows Standard Operation Procedures (SOPs) in coordinating studies. Responsible for self-training and maintaining training records.

+ 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.

+ Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators.

+ Records study data in Frontage eSource system and source documents. Evaluates and reviews study data to ensure accuracy and completeness.

+ Assists in the reconciliation of investigational products and maintain accountability.

+ Transcribes study data from source documents to sponsor designated case report forms or records data for remote data entry if applicable.

+ Resolves data queries in conjunction with the Principal Investigator.

+ Assists Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.

+ Interacts with sponsor and Frontage senior management on subject recruitment activities, study progress updates and assists Frontage senior management with developing and tracking study budgets.

+ Participates in internal/external clinical meetings.

System One, and its subsidiaries including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

System One

Address

Secaucus, NJ
07094 USA

Industry

Healthcare

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