Fortrea
Clinical Research Associate II - Dallas, Texas - Phase I
Fortrea, Granite Heights, Wisconsin, United States
Clinical Research Associate II - Dallas, Texas - Phase I
Fortrea's Clinical Pharmacology Team is hiring a Clinical Research Associate II with Phase I experience in Dallas, Texas.
What You Will Do You will utilize your skills, knowledge, and clinical judgment to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Responsibilities
Responsible for all aspects of study site monitoring including routine monitoring and close‑out of clinical sites, maintenance of study files, conduct of pre‑study and initiation visits; liaise with vendors; and other duties, as assigned.
Responsible for all aspects of site management as prescribed in the project plans.
General on‑site monitoring.
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source documentation; monitor data for missing or implausible data.
Responsible for all aspects of registry management as prescribed in the project plans – undertake feasibility work when requested.
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow‑up of SAEs.
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
Assist with training of new employees, e.g., co‑monitoring.
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned.
Perform other duties as assigned by management.
Requirements
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
2+ years of clinical monitoring experience.
Phase I experience preferred.
Must reside in Dallas, Texas area.
The important thing for us is you are comfortable working in an environment that is:
Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline even for a few minutes will create a quality issue.
Changing priorities constantly asking you to prioritize and adapt on the spot.
Teamwork and people skills are essential for the study to run smoothly.
Technology based. We collect our data directly into an electronic environment.
What do you get? Benefits
Medical, dental, vision, life, STD/LTD (multiple insurance carriers).
401(k).
Paid time off (PTO) – Flex Plan.
Employee recognition awards.
Multiple ERGs (employee resource groups).
Target pay range: $100–113k.
Remote.
Applications will be accepted on an ongoing basis.
Learn more about our EEO & accommodations request here.
#J-18808-Ljbffr
What You Will Do You will utilize your skills, knowledge, and clinical judgment to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Responsibilities
Responsible for all aspects of study site monitoring including routine monitoring and close‑out of clinical sites, maintenance of study files, conduct of pre‑study and initiation visits; liaise with vendors; and other duties, as assigned.
Responsible for all aspects of site management as prescribed in the project plans.
General on‑site monitoring.
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source documentation; monitor data for missing or implausible data.
Responsible for all aspects of registry management as prescribed in the project plans – undertake feasibility work when requested.
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow‑up of SAEs.
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
Assist with training of new employees, e.g., co‑monitoring.
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned.
Perform other duties as assigned by management.
Requirements
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
2+ years of clinical monitoring experience.
Phase I experience preferred.
Must reside in Dallas, Texas area.
The important thing for us is you are comfortable working in an environment that is:
Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline even for a few minutes will create a quality issue.
Changing priorities constantly asking you to prioritize and adapt on the spot.
Teamwork and people skills are essential for the study to run smoothly.
Technology based. We collect our data directly into an electronic environment.
What do you get? Benefits
Medical, dental, vision, life, STD/LTD (multiple insurance carriers).
401(k).
Paid time off (PTO) – Flex Plan.
Employee recognition awards.
Multiple ERGs (employee resource groups).
Target pay range: $100–113k.
Remote.
Applications will be accepted on an ongoing basis.
Learn more about our EEO & accommodations request here.
#J-18808-Ljbffr