Baim Institute for Clinical Research · 17 hours ago
Senior Clinical Research Associate
United States
Part-time
Remote
Senior Level
5+ years expBaim Institute for Clinical Research is seeking a Senior Clinical Research Associate to perform remote and on-site monitoring activities for clinical sites. The role includes ensuring compliance with study protocols and regulatory requirements while collaborating with internal teams and external partners.
Health CareMedicalPharmaceutical
Hiring Manager
Gail Sullivan
Responsibilities
Responsible for overall on-site and remote monitoring activities of assigned clinical sites
Independently conduct all types of monitor visits onsite qualifying site assessments, recruitment, initiation, for-cause, interim and closeout, and/or remote visits as needed, in accordance with Monitoring Plan
Perform source document verification/review in accordance with Monitoring Plan
Perform drug and/or device accountability
Collect, review for appropriate content and submit regulatory documents as necessary
Review ISF and resolve essential regulatory document deficiencies in a timely manner
Perform Informed Consent Form (ICF) reconciliation, to ensure all subjects have signed the correct ICF version
Query generation and manage to resolution
Identify and resolve site level quality issues and implement Corrective and Preventative Actions (CAPAs) in a timely manner, in coordination with SM Lead and/or in-house CRA
Comply with Trial Master File (TMF) document submission timelines
Update and maintain CTMS, ensure that it is up-to-date and accurate
Provide site support, communication and coordination to assure accurate and timely completion of all contracted activities:
Effectively perform Protocol and other study training to investigator and site study staff
Schedule and conduct visits in accordance with Monitoring Plan
Collaborate with Study Team during start-up activities
Complete visit reports, confirmation letters, and follow up letters on time,in accordance with Monitoring Plan and/or Baim Institute’s SOPs and Guidelines
Close out action items identified during site visits, in a timely manner
Knowledge of pertinent study milestones
Establish a strong working relationship with site study staff and Baim Institute project team members
Responsible to schedule visits with site study staff and conduct follow-up of action items and queries
Complete expense reports per Baim Institute expense guidelines
Co-monitor as needed
Attend and participate in investigator and coordinator meetings
Assist with site preparation for audits (Regulatory Agency, Sponsor, etc.)
Attend Baim CRA meetings
Qualification
Required
BS Degree in science/health related field, or nursing experience, or other clinical trial related experience
At least 5-8 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 8 years of independent clinical monitoring
Demonstrate a high working knowledge of internal SOP's, FDA/ICH guidelines to GCP's and regulatory compliance
Demonstrate effective leadership skills
Effective communication skills
Must demonstrate in-depth knowledge of the study protocol
Maintain an effectual working relationship with Sponsors, the Principal Investigator, Site Study Staff, and Baim Institute team members
Work independently and in a team environment
High level of attention to detail and work in an organized manner
Effective ability to multi-task and work in a fast pace environment
Knowledgeable with common software packages (Word, Excel, PowerPoint, Outlook)
Knowledgeable of Clinical Trial Management System
Knowledgeable of Electronic Data Capture System (e.g InForm, IBM Clinical, iMedNet, eCOS, IWRS)
Ability to quickly learn new software packages
Willing and able to travel up to 60% of the time
Company
Baim Institute for Clinical Research
Formerly known as the Harvard Clinical Research Institute, The Baim Institute for Clinical Research is a leading, not-for-profit academic research organization (ARO) that delivers insight, innovation and leadership in today's dynamic research environment.
51-200 employees
H1B Sponsorship
Baim Institute for Clinical Research has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (9)
2022 (2)
2021 (5)
2020 (5)
Funding
Current Stage
Growth StageRecent News
MarketScreener
2025-09-15
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