We are currently seeking Experienced CRA 2s to lead and support our Full Service Outsourcing team. Open to major hub locations on the East & West Coast. 60-70% travel, 8-10 DOS per month.
WHAT YOU WILL D
O
You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standard
s.
Responsibiliti
- es: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 assigne
- d -Responsible for all aspects of site management as prescribed in the project pl
- ansGeneral On-Site Monitor
- ingEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the st
- udyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requireme
- ntsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible d
- ataResponsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when reques
- tedComplete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of S
- AEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managem
- entAssist with training of new employees, eg. co-monitor
- ingCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assig
- nedPerform other duties as assigned by managem
ent
Requirem
- entsUniversity or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licens
- ure)1-3 years of Clinical Monitoring experi
- enceOpen to various hub locat
ions
The important thing for us is you are comfortable working in an environment tha
- t is:Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality i
- ssue.Changing priorities constantly asking you to prioritize and adapt on the
- spot.Teamwork and people skills are essential for the study to run smoo
- thly.Technology based. We collect our data directly into an electronic environ
ment.
What do yo
u get?
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limi
- ted to:Medical, Dental, Vision, Life, STD/LTD (multiple insurance ca
- rriers
- )401(K)Paid time off (PTO) – Fl
- ex PlanEmployee recognition
- awardsMultiple ERG’s (employee resource
- groups)Target Pay Range (based on title): $1
05-117K
Work Envi
- ronment:Work is performed in an office environment with exposure to electrical office eq
- uipment.Frequent travel to clients/ site locations with occasional travel both domestic and intern
ational.
Physical Requ
- irements:Ability to sit for extended periods and operate a vehicl
- e safely.Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, an
- d wrists.Occasional crouching, stooping, with frequent bending and twisting of upper body
- and neck.Ability to access and use a variety of computer software developed both in-house and off-t
- he-shelf.Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 1
- 5-20 lbs.Regular and consistent at
- tendance.Varied hours may be
required.