Clinical Research Coordinator - II

Job Highlights:

The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC will complete all study-related procedures and distribute study medications and instructions to research subjects under the direction of the Investigators, Site staff, CROs, and Sponsors. They will maintain accurate confidential files and documentation of the study participants. The CRC will also engage in the explanation of what is expected of the research subjects and understand their concerns, requiring excellent interpersonal and communication skills. All duties are carried out in accordance with the company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable Local, State, and Federal regulations.

Job functions:

Review study protocols and complete study training. Ensures the team receives access, approvals, and study supplies before study initiation. Attends I.M., S.I.V., and any other training session required by the Sponsor. Develop their source documents following the Site's templates and give them to their direct supervisor for approval. Meets with the Regulatory Department to ensure that the study is captured correctly in the system, including the window period between study visits, and verifies the patient stipend reflects the same amount as in the ICF. Reviews Team Leaders Weekly Report prepared by Team Lead CRC at a weekly meeting to discuss the week's progress, performance, and the upcoming week's work. Meets with the Laboratory personnel, Assistant Coordinator, and Recruitment Department before the study's initiation to train them on the protocol. Ensures study staff is aware and has been trained in the latest protocol amendment. Ensures that all personnel listed on the Delegation Log have completed all the training required by Sponsors and have obtained access to vendor portals. Reviews and maintains each tab of the Regulatory Binder. Consents study participants following the Site's SOPs. If data entry personnel are not available, the CRC must enter the subject's data in EDC within 24 hours of the visit being performed. Keep the Site's internal system updated regarding the subject status in the trial. Ensures all deviations, violations, AEs, and SAEs are captured, recorded, followed, and reported to Sponsor/IRB in a timely manner. Performs study-related procedures in compliance with protocols and the Site's SOPs. Target enrollment goals and maintain a close line of communication with the study subjects to keep them engaged in the trial while trying to achieve a higher retention rate. Ensures that the Laboratory is following protocol requirements and that all samples are successfully packed and sent to the Central/Local Laboratory, as indicated. Ensures proper follow-up through telephone contacts or certified letters when subject and emergency contact are not responding, continuing following up with subjects that have missed their appointments until they come back for their visit or are declared LTFU. Confirm with the Front desk personnel, Laboratory technicians, and Assistant CRC, subjects scheduled for the following day. Assists Clinical Research Associates or Auditors during on-site or remote monitoring visits, answering any queries generated and resolving pending action items within 7 days of the monitoring visit. Maintains PI/Sub-I/Lead CRC and is always informed on all aspects of the trial. Completes additional tasks as required by a specific protocol. This position reports to the Team Lead Clinical Research Coordinator.

Qualifications:

Works well in a team environment. Certified Clinical Research Coordinator preferred. Strong knowledge of the clinical research process, including Regulatory requirements, Good Clinical Practices (GCP), HIPAA and International Conference of Harmonization (ICH) guidelines. Clinical Terminology proficiency. Excellent written and verbal communication skills. High attention to detail and organization. Ability to multitask. Bi-lingual English/Spanish required. Ability to work after hours and weekends if needed. Knowledge of Microsoft Office 365.

Education and Experience:

Associate degree or its equivalent required, Bachelor's degree on related field preferred. Foreign Medical Graduate, Registered Nurse, or Registered Medical Assistant. 2+ years of Clinical Research experience preferred.

Job Type:

Full-time Schedule:

Monday to Friday - 8:00 am - 4:30 pm, unless otherwise indicated.

Benefits:

Medical, Dental, and Vision Insurance Life Insurance (includes Will Preparation, Employee Assistance Program (EAP), and Travel Assistance) Short & Long-Term Disability Workers' Compensation Insurance COBRA Continuation Coverage 401(k) Retirement Savings Plan with employer match Paid Time Off (PTO) Paid Holidays Bereavement Leave Family and Medical Leave Act (FMLA)

Military Leave Referral Program Tuition Assistance/Professional Development Certification Reimbursement Pay:

$21.00 - $28.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Referral program Vision insurance

Experience:

Research :

3 years (Required)

Work Location:

In person