Clinical Research Coordinator II

Posted 2 Days Ago
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CCAHAU Main Campus, Hisar Police Line Area, Hisar, Haryana, IND
In-Office
Mid level
Healthtech • Social Impact • Biotech • Pharmaceutical
The Role
Coordinate and monitor clinical research trials ensuring regulatory compliance (IRB, FDA, GCP/ICH, HIPAA). Screen and recruit participants, perform protocol procedures (vitals, ECGs, specimen handling), maintain records and budgets, assist with IRB submissions, and support operational and financial functions under PI supervision.
Summary Generated by Built In
The Clinical Research Coordinator II (CRC II) will be responsible for coordinating advanced clinical research projects proficiently with supervision. Functions independently, and is able to identify situations where additional support is necessary. Independently able to access regulations governing the protection of human subjects- IRB, FDA, OHRP, GCP/ICH and HIPAA guidelines and apply regulations in practice. The CRC II will assure that the integrity and quality of clinical research trials is maintained and the trials are conducted in accordance with all Meharry Medical College, IRB, and NIH policies and standard operating procedures. Responds to inquiries on study projects, ensures compliance of protocols and overall objectives, and performs study-related procedures of clinical research under the supervision of the Principal Investigators. The CRCII will assist with the operational and financial functions of the Center of Excellence for Clinical and Translational Research.

Essential Functions (Duties and Responsibilities) – Assign a percentage to each essential function:

  • Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses and travel to participant’s location for recruitment activities  
  • Maintain required records of study activity including case report forms, consenting research subjects, or regulatory forms.
  • Performs standard accounting functions, monitors and reviews accounting and related system reports for accuracy and completeness; prepares and reviews budget, revenue, expenses, invoices, and other accounting documents; Responsible for collecting and documentation of monies collected in clinical research. Responsible for managing accounts receivable and accounts payable in clinical research; Assist with reviews, analyzes and negotiates all clinical research budgets and contracts with sponsors under the direction of the Principal Investigator/ Associate Director
  • Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms. Direct the requisition, collection, Processing of samples, labeling, storage, or shipment of specimens.
  • Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
  • Schedules subjects for appointments and procedures as required by study protocols. Inform patients or caregivers about study aspects and outcomes to be expected.
  • Assists with preparing IRB submissions, protocol revisions, and renewals as needed, and maintain copies of all IRB communications delegated by the Principal Investigator.
  • Performs other related duties as assigned.

                                                                                                                             

Knowledge, Skills and Abilities:

  • Must possess a good working knowledge of basic clinical research practice.
  • Must be proficient with personal computer.
  • Ability to utilize keen judgment in evaluating information.
  • Ability to numerically and accurately enter and calculate test results in an electronic database.
  • Ability to work in a stressful environment.
  • Must be team oriented.

Education and Experience:

  • Graduated from an accredited discipline specific program with a bachelor’s or master’s degree in science
  • Prior Clinical research experience in a patient care setting preferred (Experience as an LPN or travel phlebotomist or clinical research experience preferred). 

Equal Employment Opportunity Statement

Meharry Medical College complies with Title IX and is an affirmative action employer. Candidates will be considered for employment without discrimination for an non-merit reason such as race, color, national origin, sex, religion, age, handicap or veteran status.

Skills Required

  • Bachelor's or Master's degree in a science discipline
  • Working knowledge of clinical research practices and human subjects protections (IRB, FDA, OHRP, GCP/ICH, HIPAA)
  • Proficiency with personal computer and electronic databases
  • Ability to perform protocol procedures (screening interviews, vitals, ECGs, specimen collection/processing/labeling/shipment)
  • Experience with clinical research in a patient care setting (LPN, phlebotomist, or CRC experience)
  • Experience or ability to manage study-related finances: budgets, accounts receivable/payable, invoices
  • Ability to accurately enter and calculate test results in electronic databases
  • Ability to utilize judgment in evaluating information and work in stressful environments; team oriented
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The Company
3,000 Employees

What We Do

Meharry Medical College is the nation's largest private, independent historically Black academic health sciences center. It is a global center advancing health equity through innovative research, transformative education, and compassionate health services. Dedicated to improving the well-being of humankind, Meharry focuses on educating healthcare professionals to serve disadvantaged populations, continuing a nearly 150-year legacy of excellence in medicine, dentistry, and community service.

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