Clinical Research Coordinator III (4082)

DM CLINICAL RESEARCH GROUP•Phoenix, AZ

8d•Onsite

About The Position

This role ensures that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines. The primary goals are to provide the best quality data to the sponsor and ensure study enrollment meets or exceeds sponsor expectations, contributing to the achievement of company goals on a timely basis.

Requirements

High School Diploma or equivalent required
Minimum of 5 years experience in Clinical Research
Goals-driven while continuously maintaining quality.
Must be detailed-oriented, proactive, and able to take initiative.
Must have strong written and communication skills.
Must have excellent customer service skills.
Proficient communication and comprehension skills both verbal and written in the English language are required.

Nice To Haves

Bachelor's degree preferred
Foreign Medical Graduates preferred
Supervisory experience preferred
Wide therapeutic range of clinical trials experience preferred
Regulatory research experience is a plus
ACRP or equivalent certification is preferred
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

Responsibilities

Completing all DMCR-required training, including ICH-GCP Certification and IATA Certification.
Completing all relevant training prior to study-start and on a continued basis, including sponsor-provided and IRB-approved Protocol Training, Protocol Amendments Training, study-specific Manuals Training, and Sponsor-specified EDC and/or IVRS and other relevant Electronic Systems training.
Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
Adhering to ALCOA-C Standards with all relevant clinical trial documentation.
Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and sponsor expectations.
Demonstrating appropriate and timely follow-up on action items at respective sites.
Demonstrating understanding, implementation, and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants, and Sponsor/CRO representatives for assigned protocols.
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all organizational SOPs, all guidance documents, and assigned study protocol(s).
Maintaining a working knowledge of the recruitment and retention process for assigned protocols at respective sites.
Training and mentoring site staff, as needed.
Supervising visit preparedness for all relevant sponsor and CRO visits for assigned protocols.
Maintaining a working knowledge of the most recent versions of Study Protocols, Informed consents, Study Manuals, and all other relevant study-related documents.
Maintaining a working knowledge of Study Participants’ Scheduling, Visit Tracking, Stipends, and Transportation by liaising with the Administrative team.
Maintaining a working knowledge of Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for assigned protocols.
Overseeing reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
Striving to meet Sponsor subject enrollment goals for assigned protocols at respective sites.
Being prepared for and available at all required company meetings.
Submitting required administrative paperwork per company timelines.
Occasionally attending out-of-town Investigator Meetings.
Conducting patient consent discussions and ensuring comprehension of medical procedures, risks, benefits, and alternatives.
Providing clear explanations of study protocols and ensuring patients' understanding before obtaining their consent.
Facilitating effective communication between patients, healthcare providers, and research staff.
Performing any other matters as assigned by management.