Clinical Research Associate (Midwest-Based)
This role offers an experienced Clinical Research Associate the opportunity to move into a sponsor-side environment and play a central role in managing and monitoring Phase III clinical trials. You will oversee site-level clinical operations, ensure adherence to protocols and regulatory requirements, and work closely with cross-functional study teams to support the delivery of potentially life-changing therapies. The position is based in the Midwest and involves extensive travel to investigative sites, strong visibility within the clinical program, and meaningful ownership of site performance and study outcomes.
Responsibilities
- Manage and monitor clinical trial activities at assigned study sites to ensure compliance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
- Serve as the primary point of contact for investigators and site staff, fostering strong and collaborative relationships.
- Plan, conduct, and document all required site visits, including Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
- Perform comprehensive site management activities to ensure project timelines, milestones, and deliverables are met.
- Leverage in-depth knowledge of the study protocol to safeguard subject safety, ensure protocol compliance, and protect the integrity and validity of study data.
- Ensure all site management and monitoring activities are conducted in compliance with ICH-GCP, standard operating procedures (SOPs), the Clinical Monitoring Plan (CMP), study plans, and applicable local laws and regulations.
- Verify the accuracy and completeness of study data through detailed source data review and source data verification (SDR/SDV).
- Conduct initial and ongoing training and retraining of site staff on protocol requirements, study procedures, and study-specific tools as needed.
- Manage site-level queries, protocol deviations, and operational issues, escalating concerns appropriately and in a timely manner.
- Ensure investigative sites update clinical trial data systems accurately and within required timelines.
- Oversee timely and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and drug safety (DS) events, including appropriate follow-up to completion.
- Prepare, submit, and maintain high-quality visit reports, follow-up letters, and related documentation within required timelines.
- Maintain accurate, complete, and up-to-date study files, including regulatory documents and monitoring records.
- Support and facilitate site audits and regulatory inspections by ensuring inspection readiness and addressing findings as needed.
- Contribute to site feasibility assessments and support the development and execution of patient recruitment strategies.
- Act as a liaison between investigative sites and the sponsor, ensuring effective communication, timely issue resolution, and alignment on study expectations.
- Collaborate with sites to develop, adapt, and track subject recruitment plans that align with project needs and enhance enrollment predictability.
- Attend project meetings and provide clear, concise updates on site status, enrollment progress, and key operational metrics.
- Identify operational risks at the site level and recommend appropriate mitigation strategies.
- Ensure safety events and other reportable occurrences are properly documented, followed, and closed to completion in collaboration with safety surveillance.
- Lead and conduct presentations to internal teams, site personnel, and other stakeholders as needed.
- Coordinate, organize, and manage clinical study coordinator teleconferences on a routine basis when required.
- Collaborate with contract research organizations (CROs) and vendors to manage site-level activities and resolve operational challenges.
- Contribute to patient recruitment and retention initiatives and support long-term site relationship management.
- Operate effectively in a fast-paced, dynamic environment by proactively addressing issues, proposing solutions, and maintaining focus on study goals.
Essential Skills
- Minimum 5 years of onsite clinical monitoring experience, including experience with Phase III clinical trials.
- Demonstrated experience in a sponsor environment or working closely with sponsors on clinical programs.
- Strong knowledge of and skill in applying clinical research regulatory requirements, including ICH-GCP guidelines.
- Experience in site management, including planning and conducting SQV, SIV, IMV, and COV visits.
- Proven ability to manage serious adverse events in collaboration with safety surveillance teams, ensuring events are followed through to completion.
- Effective organizational, communication, and interpersonal skills, with the ability to build strong relationships with site personnel and internal stakeholders.
- Ability to lead and conduct presentations for internal teams and site staff.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.
- Proficiency with the Microsoft Office suite, including Word, Excel, PowerPoint, and Outlook.
- Strong analytical and problem-solving abilities, with the capacity to identify risks and propose mitigation strategies.
- Experience working in a fast-paced, collaborative environment with shifting priorities.
- Effective time management and financial management skills to support efficient site operations.
- Willingness and ability to travel up to 80%, including frequent overnight stays.
- Bachelors degree in a scientific discipline or healthcare-related field (preferred).
Work Environment
The role is based in the Midwest and involves frequent travel to investigative sites, with up to approximately 80% travel including overnight stays. You will work in a smaller, performance-driven clinical-stage environment where individual contributions are highly visible and closely tied to the success of the clinical program. The culture emphasizes collaboration, innovation, and action, and is best suited for proactive, solutions-oriented professionals who are comfortable taking initiative rather than waiting for direction. Clinical Operations team members are expected to take strong ownership of their studies, manage challenges directly with CROs and vendors, and bring forward practical solutions.
Job Type & Location
This is a Permanent position based out of Pennington, NJ.
Pay and Benefits
The pay range for this position is $130000.00 - $130000.00/yr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Annual bonus: 1015% 401(k): 5% company match Tuition reimbursement: Up to $8,000/year Cell phone reimbursement: $125/month Paid time off: At least 10 vacation days + 5 sick days Paid holidays: 12/year Healthcare: Medical and dental coverage Additional: Employee rewards/recognition program Benefits should be confirmed for the specific FTE offer, as eligibility and plan details may vary.
Job Type & Location
This is a Permanent position based out of Pennington, NJ.
Application Deadline
This position is anticipated to close on Nov 6, 2026.
Workplace Type
This is a fully remote position.
About Actalent
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