Experienced CRA 2

Visa Hunt; United States; On-site; USD 105,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision, life, STD/LTD

401(K)

PTO – Flex Plan

Employee recognition awards

Multiple ERGs

Job summary

Visa Hunt is seeking an experienced CRA 2 to lead and support our Full Service Outsourcing team. This remote US role requires handling clinical trial monitoring with 60-70% travel and 8-10 DOS per month.

You will monitor study sites, ensure regulatory compliance, manage data quality, and coordinate with vendors. The ideal candidate has a University degree and 6 months to 2 years of monitoring experience and is comfortable in a fast-paced, team-driven environment.

Qualifications

• University or college degree, or certification in a related allied health profession.
• 6 months - 2 years of clinical monitoring experience.
• Open to various hub locations.

Responsibilities

• Monitor clinical sites, conduct visits, and maintain study files.
• Ensure adherence to protocol, regulatory requirements, and informed consent.
• Manage data integrity in CRFs and data collection tools.
• Coordinate local project activities and act as client contact as assigned.
• Support training of new staff and assist with feasibility work.

Skills

Clinical monitoring

Site management

Regulatory compliance

Coordination/communication

Teamwork

Education

University degree or allied health credential

Tools

Electronic data capture (EDC)

Job description

Job Title: Experienced CRA 2

Job Location: Remote United States

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

We are currently seeking experienced CRA 2s to lead and support our Full Service Outsourcing team. Open to major hub locations within the US. 60-70% travel, 8-10 DOS per month.

WHAT YOU WILL DO

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 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 document 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 repo11s, 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, eg. 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)
• 6 months -2 years of Clinical Monitoring experience
• Open to various hub locations

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 for even 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?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO) – Flex Plan
• Employee recognition awards
• Multiple ERG’s (employee resource groups)
• Target Pay Range (based on title): $105-125K

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and 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-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.