In-House Clinical Research Associate (Contract)

GENERAL SUMMARY

4DMT seeks a motivated and detail-oriented In-House Clinical Research Associate (IHCRA) to support the Company’s clinical trial activities. This position reports to the Senior CTM, Clinical Operations, and will support the day-to-day execution of a Phase 3 clinical trial, including study start-up, conduct, and close-out activities.

The IHCRA will serve as a key liaison between 4DMT, clinical sites, and CRO partners, with a focus on site support, monitoring oversight, regulatory compliance, and data quality. This role requires strong written and verbal communication skills, excellent organizational skills, and the ability to manage competing priorities while delivering high-quality work in a fast-paced, team-oriented environment.

MAJOR DUTIES & RESPONSIBILITIES:

Clinical Trial Operations & Site Support

• Support study execution across start-up, conduct, and close-out phases
• Serve as a primary point of contact for assigned clinical sites and CRO field CRAs/monitors
• Communicate directly with sites and CRO partners to obtain updates, resolve issues, and support study timelines
• Support site initiation, ongoing site management, and site close-out activities
• Assist with identification, documentation, tracking, and follow-up of site issues

Monitoring Oversight

• Support oversight of CRO monitoring activities
• Review monitoring visit reports and follow up on action items and unresolved findings
• Track monitoring deliverables and escalate issues to the Associate Director, Clinical Operations as appropriate
• Support inspection readiness and audit activities

Tracking & Study Oversight

• Maintain accurate tracking tools for assigned studies, including:
• Site start up and activation status
• Subject enrollment and visit status
• Essential document collection and TMF status
• Vendor reconciliation
• Assist with preparation of study status reports and metrics

Regulatory Documentation & TMF Management

• Collect, review, and track site regulatory documents for completeness, accuracy, and compliance with applicable SOPs and regulatory requirements
• Ensure timely filing of documents in the TMF/eTMF in accordance with TMF plans
• Perform TMF quality control activities and support TMF audits and study close out

Study Communications & Meetings

• Support organization and coordination of internal team meetings, investigator meetings, and other study related meetings
• Prepare meeting materials, take meeting minutes, and maintain action item logs
• Support communication of study updates to internal stakeholders

Additional Responsibilities

• Support ad hoc Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (<5% anticipated)
• Other duties as assigned, nothing in this position description restricts management’s right to assign or reassign duties and responsibilities to this position at any time 

QUALIFICATIONS: 

Education: 

• A. or B.S. degree required

Experience: 

• Minimum of 1-2 years of experience supporting clinical trials in a sponsor or CRO environment
• Experience supporting Phase 3 clinical trials preferred
• Ophthalmology Preferred

Other Qualifications/Skills: 

• Working knowledge of clinical trial operations and ICH GCP guidelines
• Experience with TMF/eTMF systems (Veeva Vault preferred)
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Strong organizational skills and attention to detail
• Ability to manage multiple priorities and meet deadlines
• Strong interpersonal skills and ability to collaborate effectively with cross functional teams and external partners

Travel: Willingness to travel as business needs demand (<5% anticipated)

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Hourly compensation range: $60.00 - $70.00/hr

Please note, the compensation range and actual rate offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.