Clinical Research Coordinator Position Available In Somerset, New Jersey
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Job Description
General Summary:
Non-exempt position. The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Principal Investigator and the Clinical Research Supervisor. The CRC will develop, implement, and coordinate research and administrative procedures for successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and exhibit a high-level knowledge of study specific protocols. Essential Job Responsibilities include, but not limited to the following: Administratively and clinically manage multiple clinical trials, simultaneously. Adhere to Research SOPs, Good Clinical Practices, and the study protocols. Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials. Assist the Principal Investigator (PI) in identifying prospective candidates for upcoming clinical trials. Review and verify all relevant source documents with the PI to confirm patients’ eligibility. Assist Clinical Research Supervisor with regulatory files or work directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. Review study protocol and follow-up procedures with potential study patients Provide patients education on an ongoing basis throughout their participation in the clinical trial. Complete visit procedures which may include but would not be limited to administering injections, obtaining vital signs, performing ECGs, and collecting blood samples for processing and shipment to the appropriate lab facility. Complete and maintain case report forms (CRF) per FDA guidelines, GCP, and protocol requirements. Review CRF against the patient’s record for completeness and accuracy. Ensure that all data and/or all queries are entered and addressed, respectively in a timely manner in the appropriate electronic data capture (EDC) database. Other duties as assigned.
Education:
High school diploma or higher.
Experience:
Minimum 1-year clinical research experience, past medical experience preferred
Other Requirements:
GCP required. IATA Certification to be obtained within 30 days of hire
Performance Requirements:
Knowledge:
1. Knowledge of medical terminology
Skills:
1. Detail-oriented, organized, and manage deadlines 2. Must be proficient in Microsoft Office Word and Excel, electronic health systems and electronic data capture (EDC) databases.
Abilities:
1. Ability to be flexible, multi-task, work independently as well as in team environment.
Equipment Operated:
Standard clinical equipment and supplies including, EKG, blood pressure machine, thermometer, oxygen tank, AED, syringes, pulse oximetry unit as well as computers, fax machines, copiers, printers and telephone.
Work Environment:
Research office and medical exam/treatment rooms. Controlled lighting, air quality and temperature settings. Environmental hazards may be unpredictable including exposure to communicable diseases and biohazards.
Pay:
$25-$35 per hour
Benefits:
401(k) Dental insurance Employee discount Health insurance Life insurance Paid time off Tuition reimbursement Vision insurance
Requirements Education:
High school diploma or higher.
Experience:
Minimum 1-year clinical research experience, past medical experience preferred
Other Requirements:
GCP required. IATA Certification to be obtained within 30 days of hire
Performance Requirements:
Knowledge:
1. Knowledge of medical terminology
Skills:
1. Detail-oriented, organized, and manage deadlines 2. Must be proficient in Microsoft Office Word and Excel, electronic health systems and electronic data capture (EDC) databases.
Abilities:
1. Ability to be flexible, multi-task, work independently as well as in team environment.
Equipment Operated:
Standard clinical equipment and supplies including, EKG, blood pressure machine, thermometer, oxygen tank, AED, syringes, pulse oximetry unit as well as computers, fax machines, copiers, printers and telephone.
Work Environment:
Research office and medical exam/treatment rooms. Controlled lighting, air quality and temperature settings. Environmental hazards may be unpredictable including exposure to communicable diseases and biohazards.
Mental and Physical Requirements :
Involves standing, walking, bending, grasping, manipulating, squatting, and lifting up to 50 pounds.
Other Requirements:
Influenza:
All employees of ID Care shall be provided the influence vaccine. Employees will be required to obtain the influenza vaccine by December 1 of each calendar year.
Covid:
As of 8/1/2021, current ID Care employees will be required to be fully vaccinated. Employees may receive the vaccine from a provider, pharmacy, or outside health facility of choice.
Staff are considered fully vaccinated:
2 weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. Effective 1/3/2022 Administration of an additional dose of vaccine 2 months after a JNJ vaccine and 6 months after an mRNA vaccine (Moderna or Pfizer) are required to be fully vaccinated. ID Care is an Equal Opportunity Employer who does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
