Clinical Research Coordinator II

Dm Clinical Research Group; Irving (TX); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

DM Clinical Research Group seeks a Clinical Research Coordinator II in Frisco, TX to ensure compliant, high-quality research at investigative sites and deliver top data quality to the sponsor. The role requires training, visits, data handling, and communication with sponsors, CROs, investigators, and patients.

The candidate will perform ALCOA-C compliant documentation, support enrollment targets, and uphold regulatory standards and study procedures across assigned protocols.

Qualifications

• High School Diploma or equivalent required; Bachelor's degree preferred.
• At least 2 years of CRC experience, preferably coordinating industry-sponsored vaccines.
• Proficient communication in English; bilingual English/Spanish preferred.

Responsabilités

• Conduct study subject visits and document procedures per protocol.
• Maintain ALCOA-C standards in all trial documentation.
• Perform data entry and resolve queries in a timely manner.
• Support enrollment goals and sponsor/CRO communications.
• Coordinate training and adherence to FDA, ICH-GCP guidelines.
• Ensure patient privacy and professional conduct at all times.

Connaissances

Detail-oriented

Multi-tasking

Proficient communication

Bilingual EN/ES preferred

Formation

High School Diploma or equivalent

Bachelor's degree preferred

Foreign Medical Graduates preferred

Outils

EDC

IVRS

Description du poste

The Clinical Research Coordinator II (Frisco, TX) will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.DUTIES & RESPONSIBILITIESCompleting all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:Sponsor-provided and IRB-approved Protocol TrainingAll relevant Protocol Amendments TrainingAny study-specific Manuals Training, as applicableSponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.Demonstration of appropriate and timely follow-up on the action items, at their respective sites.Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.Demonstrating adherence and compliance to the assigned protocols at their respective site(s).Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).Oversee 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.Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).Being prepared for and available at all required company meetings.Submitting required administrative paperwork per company timelines.Occasionally attending out-of-town Investigator MeetingsConduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternativesProvide clear explanations of study protocols and ensure patients' understanding before obtaining their consentFacilitate effective communication between patients, healthcare providers, and research staffAny other matters as assigned by management.KNOWLEDGE & EXPERIENCEEducation:High School Diploma or equivalent required; Bachelor's degree preferredForeign Medical Graduates preferredExperience:At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.Credentials:ACRP or equivalent certification is preferredKnowledge and Skills:Be an energetic, go-getter who is detail-oriented and can multi-task.Be goals-driven while continuously maintaining quality.Proficient communication and comprehension skills both verbal and written in the English language are required.Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.All employees of DM Clinical Research, In any capacity, are expected to:Always treat others with dignity and respectAlways conduct themselves in an ethical mannerComply with all local, state, and Federal, including FDA, regulations pertaining to the conduct of clinical trials on human subjectsComply with departmental and company expectations, policies, and procedures at all timesReport to work as scheduled and seek approval from your supervisor in advance for any changes to the established work schedule, including the use of leave and late or early arrival and departures.Perform assigned duties and responsibilities with the highest degree of trust.Protect patient privacy at all times by keeping discussion of names and medical conditions confined to private locations, out of earshot of anyone not employed by DMCR.Be polite, upbeat, and professional, on the phone and in person.Maintain a high level of professionalism with CRAs and any Sponsor or CRO employee or representative