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Remote Edc Programmer Jobs in California (NOW HIRING)

Intuitive

Senior Clinical Study Manager

Sunnyvale, CA · On-site +1

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery ... Perform on-site and remote site qualification visits, site initiation visits, interim monitoring ...

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Remote Edc Programmer information

What is the difference between Remote Edc Programmer vs Remote Clinical Data Coordinator?

AspectRemote Edc ProgrammerRemote Clinical Data Coordinator
Required CredentialsTypically requires a degree in computer science, life sciences, or related field; proficiency in EDC systemsUsually requires a degree in health sciences, life sciences, or related; knowledge of clinical data management
Work EnvironmentPrimarily focused on programming and system setup within clinical trialsOversees data collection, entry, and quality control in clinical studies
Employer & Industry UsagePharmaceutical companies, CROs, biotech firmsPharmaceutical companies, CROs, research institutions

The Remote Edc Programmer primarily focuses on designing and programming electronic data capture systems for clinical trials, requiring technical programming skills. In contrast, the Remote Clinical Data Coordinator manages data collection and quality assurance processes. Both roles are essential in clinical research but differ in technical focus and daily responsibilities.

What is a Remote EDC Programmer?

A Remote EDC Programmer is a professional who designs, develops, and manages Electronic Data Capture (EDC) systems for clinical trials or research studies, working from a remote location. They are responsible for programming databases, building electronic case report forms (eCRFs), and ensuring that data collection processes meet regulatory and quality standards. EDC Programmers collaborate with clinical teams to customize systems according to study protocols and troubleshoot technical issues to ensure smooth data collection and management. Their remote role allows them to work with organizations and clients globally, leveraging secure communication and data tools.

What are the key skills and qualifications needed to thrive as a Remote EDC Programmer, and why are they important?

To thrive as a Remote EDC (Electronic Data Capture) Programmer, you need a solid background in clinical data management, database design, and programming languages such as SQL, often supported by a degree in computer science or a related field. Familiarity with EDC systems like Medidata Rave, Oracle InForm, and knowledge of relevant regulatory standards (e.g., CDISC, FDA 21 CFR Part 11) are typically required. Strong problem-solving skills, attention to detail, and effective communication are essential soft skills for collaborating remotely with cross-functional clinical teams. These skills ensure accurate data capture, regulatory compliance, and efficient study execution in clinical trials.

What are some common challenges Remote EDC Programmers face when collaborating with cross-functional teams, and how can they overcome them?

Remote EDC Programmers often work closely with data managers, clinical trial coordinators, and statisticians, which can present challenges such as time zone differences, communication barriers, and varying technical expertise. Overcoming these challenges typically involves using clear documentation, regular virtual check-ins, and collaborative platforms to ensure alignment on project goals and timelines. Building strong relationships with team members and proactively addressing issues can also help ensure smooth collaboration and successful study database development.
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Remote Edc Programmer jobs near you
Sr. Clinical Research Associate (Field)

Sr. Clinical Research Associate (Field)

Shifamed

Los Gatos, CA • On-site, Remote

$120K - $140K/yr

Full-time

Posted 24 days ago

Job description

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com.
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description:

We are seeking one field-based Senior Clinical Research Associate (Senior CRA) who will play a critical role in monitoring and managing clinical trial site activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. These are full time, remote positions with anticipated travel of up to 80%.

Preferred geographic locations: GA, NC, SC, TN, or VA

  • Southeast (1): GA, NC, SC, TN, or VA
Responsibilities, Skills amp; Hands-On Experience:
  • Serve as the primary point of contact for investigative sites, fostering strong and collaborative site relationships.
  • Monitor patient data and clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
  • Lead and conduct on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) to assess site performance, resolve issues, and provide support to ensure successful trial execution.
  • Critically review clinical data to ensure accuracy, completeness, and integrity in alignment with EDC systems and clinical data management standards.
  • Engage site staff in development of enrollment targets, tracking enrollment progress, and troubleshooting patient recruitment issues.
  • Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
  • Maintain oversight of investigational product accountability, tracking, and reconciliation for cardiovascular devices.
  • Partner closely with internal stakeholders to align clinical activities with business and regulatory objectives.
  • Identify, document, and assist in resolving protocol deviations and CAPAs.
  • Participate in internal audits and support readiness for regulatory inspections.
Education amp; Work Experience:
  • Bachelor’s degree in life sciences, nursing, biomedical engineering, or related discipline.
  • 5+ years of experience in clinical research, including at least 3 years of independent monitoring for medical device trials. Experience in IDE studies strongly preferred.
  • Prior experience in cardiovascular or interventional device studies strongly preferred.
  • Strong working knowledge of GCP, ISO 14155 and FDA guidelines.
  • Proficient in EDC, eTMF, and Microsoft Office tools.
  • Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $120,000 - $140,000 + equity + benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.

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