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Clinical Research Coordinator

newark, nj • Posted 1 weeks ago

Onsite Contract Bio & Pharmacology & Health

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The Clinical Research Coordinator will oversee the day-to-day operations of clinical trials, ensuring they are conducted ethically and according to protocol.

Key Activities

Protocol Familiarization : Understanding the clinical trial protocol, procedures, and objectives.
Regulatory Compliance : Ensuring the study complies with regulatory guidelines, including Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements.
Site Preparation : Setting up study sites with necessary equipment, documents, and supplies.
Recruitment : Identifying and recruiting eligible participants for the study.
Screening : Conducting screening procedures to determine participant eligibility according to the protocol.
Informed Consent : Ensuring participants provide informed consent after fully understanding the study details.
Data Collection : Collecting accurate and timely data during participant visits.
Protocol Adherence: Ensuring all study procedures are conducted per protocol.
Participant Monitoring : Monitoring participant safety, reporting adverse events, and maintaining follow-up schedules.
Specimen Handling: Collecting, processing, and shipping biological samples as required.
Case Report Forms (CRFs): Completing and maintaining CRFs and source documents.
Regulatory Documents : Keeping trial master files and essential regulatory documents updated.
Adverse Event Reporting : Reporting adverse events or protocol deviations to the IRB, sponsor, or regulatory agencies as necessary.
Sponsor Interaction : Liaising with study sponsors, contract research organizations (CROs), and monitors.
Team Coordination : Coordinating activities with the study team, including the PI, nurses, and lab staff.
Participant Communication : Serving as the primary contact for participants regarding study-related inquiries.
Audits and Inspections : Preparing for and participating in audits, inspections, and monitoring visits.
Data Integrity : Ensuring data accuracy and resolving data discrepancies.

Preferred Skills

Good Clinical Practices (GCP), Cardio Pulmonary Resuscitation (CPR), Advanced Life Support (ALS).
Strong organizational, communication, and interpersonal skills.

Educations & Experience

Bachelor's degree in health sciences, nursing, biology, or a related field.
1–3 years of clinical research experience

Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.

TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.

Accommodation for applicants with disabilities is available upon request.

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We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attached your resume to your application.

Job ID: 7831

Seniority level

Seniority level
Associate

Employment type

Employment type
Full-time

Job function

Job function
Research
Industries
Hospitals and Health Care, Pharmaceutical Manufacturing, and Biotechnology Research

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