Serve as Medical Monitor for assigned clinical trials, reviewing emerging medical/safety data and collaborating with CRO partners.
Play an active role in planning, conduct, and evaluation of ongoing clinical trials to ensure successful execution.
Contribute to authoring and critical review of regulatory documents and scientific data disclosures.
Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases such as MASH. They foster a collaborative culture among a diverse team of problem solvers.
Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.
Prepare and manage clinical trial submissions to Competent Authorities and Ethics Committees for initial and subsequent approvals.
Collect, review, and maintain essential documents for site activation, ensuring compliance with ICH-GCP and local regulations.
Act as Subject Matter Expert, mentoring less-experienced staff on site start-up activities and regulatory requirements.
Precision Medicine Group is a life sciences organization that provides clinical trial and regulatory services to biopharmaceutical companies. They are expanding their presence in Latin America and foster a collaborative, fast-paced culture focused on precision medicine.
You will monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted per protocol, SOPs, ICH-GCP, and regulations.
You will coordinate all necessary activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
You will identify potential study risks and propose solutions to mitigate them, demonstrating an impeccable eye for detail.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease, and are proud to share extremely high CRA retention rates compared to industry averages.
Serve as the site manager, ensuring data entry and query resolution, and maintain high-quality data and audit readiness at clinical sites.
Monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting, both onsite and remotely.
Manage device accountability, inventory, distribution, and regulatory documentation to ensure compliance and audit readiness.
Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products for challenging medical conditions. The company sells its products to hospitals and healthcare providers worldwide through direct sales and distributors.
Shape what we build by bringing doctors' real needs, workflows, and habits into the product.
Ensure clinical quality by defining standards, evaluating AI outputs, and turning errors into improvements.
Keep products safe and scalable by collaborating with regulatory, engineering, and clinical teams.
Docplanner is a global healthcare platform connecting over 300,000 doctors with 100 million patients monthly across 13 markets. Noa, a part of Docplanner, builds AI to help doctors reduce administrative work and improve patient care.
Independently conduct and document onsite and remote monitoring visits, ensuring protocol and regulatory compliance.
Serve as primary liaison between sponsor and investigative sites, managing data queries and site communications.
Mentor junior CRAs and participate in audits, inspections, and process improvement initiatives.
Alimentiv is a clinical research organization that provides clinical trial monitoring and site management services. The company fosters a dynamic, results-driven, and high-accountability environment with a focus on quality and compliance.
Provide scientific and medical direction to integrate clinical relevance into client brand strategies.
Monitor disease categories and product labeling to derive actionable insights for medical strategy.
Support senior Medical staff in new business and thought leadership while training junior team members.
Inizio Evoke is a healthcare communications agency that aims to make health more human through strategic and creative work. They foster an inclusive, authentic culture and offer flexible work environments with a focus on collaboration and professional growth.
Author aggregate safety reports including PBRER, PSUR, DSUR, and others for submissions to health authorities.
Coordinate with stakeholders to obtain data, plan timelines, and ensure timely delivery of reports.
Mentor junior team members, conduct training, and maintain awareness of regulatory guidelines.
ClinChoice partners with pharmaceutical, medical device, and consumer care companies to accelerate clinical trials and ensure product safety. With a global delivery network spanning multiple countries, they provide expertise in clinical operations, biometrics, pharmacovigilance, and more.
Manage a team of 6-14 CRAs to ensure excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP.
Provide training, support, and mentoring to CRAs, manage low or non-performance situations, and contribute to capacity planning.
Collaborate with local stakeholders, including CRMs and PLMs, to ensure alignment across monitoring functions and resolve site or CRA operational issues.
We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare, supported by a large and diverse workforce.
Manage the intake, review, analysis, and reporting of Individual Case Safety Reports (ICSRs) and support Clinical Events Committees and Data Monitoring Committees.
Co-author and maintain study-specific safety documents and prepare aggregate safety reports for regulatory submission.
Collaborate with sponsors, study teams, and cross-functional partners to ensure data quality and compliance with GCP and GVP standards.
This partner company delivers high-quality safety services across clinical research and medical device programs. They foster a collaborative, detail-oriented environment with a focus on compliance and patient outcomes.
Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
Serves as regulatory document specialist for clinical trial start-up, maintenance, and close-out.
Collects, reviews, and maintains essential documents in the electronic Trial Master File (eTMF).
Communicates with study teams and sites to ensure regulatory files remain complete and inspection-ready.
St. Jude Children’s Research Hospital is a leading research and treatment center focused on pediatric catastrophic diseases. It is a large institution with a collaborative culture and a strong emphasis on finding cures and saving children.
Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.
PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.