Jobs · Analyst · Michigan

Clinical Research Coordinator

EmVenio · Garden City, MI · 3 days ago
Analyst$56k–$77k/yrFull-time

About the role

Be a part of our dynamic client-focused team and make a difference in your career! As an on-site Clinical Research Coordinator (CRC), you will support our mission to deliver care and other services that enhance the quality of life of our clients.

Responsibilities

  • Provide technical and administrative support to your assigned clinical operations team in the field as well as direct patient care of research study participants.
  • Review documentation, coordinate clinical study project details, and maintain data systems with a sense of urgency aligned with that of our customers.
  • Conduct trial coordinator activities for EmVenio Research’s decentralized network, including assessing and following trial participants along with other trial protocol-related activities.
  • Ensure regulatory compliance and performance of assigned mobile clinics and clinician teams conducting decentralized trials as well as patient engagement and screening.
  • Timely and accurately enter EDC data and resolve queries.

Qualifications

  • Bachelor's degree (B. A. / B. S.) from four-year college or university or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
  • Two (2) years research experience strongly preferred.
  • Phlebotomy and ECGs experience not required, but preferred.
  • ACRP or SOCRA Clinical Research Certification (Preferred), Clinical Research Training Certification (Preferred).
  • Excellent computer skills, proficient in MS Word, Excel, PowerPoint, and ability to obtain knowledge and master all clinical trial database systems.
  • Proven ability to successfully coordinate multiple studies adhering to regulatory and institutional guidelines.
  • Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care, both in-person and virtually.
  • Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
  • Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency.
  • Flexibility to reprioritize workload to meet changing project timelines.
  • Responsible for adhering to FDA Good Clinical Practices, FDA regulations, EmVenio Research/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
  • Strong interpersonal skills to be able to interact with multiple people on many different levels.
  • May be responsible for basic clinical assessments.

Essential Functions/Areas Of Accountability

  • Complete study tasks as outlined by trial protocol.
  • Achieves EmVenio standards for quality, customer service, productivity and teamwork through participation in Risk and Quality Improvement programs, clinical meetings and other meetings as required.
  • Works collaboratively with nurses, physicians, nurse practitioners, physician assistants, clinical research specialists, leaders, family members, key care givers and any ancillary medical personnel as appropriate.
  • Communicates with key stakeholders such as the Principal Investigator, clinical trials team and quality department, regulatory.
  • Consults with the Site Manager and virtual Clinical Research Coordinator to ensure compliance with guidelines.
  • Reviews the medical and social history of members.
  • Aid in building the community research site network and developing relationships within that community.
  • Participate in recruitment of participants to include personally engaging the general public face to face in local across hard-to-reach communities, attending community events, speaking with physicians and people across diverse cultures and backgrounds to support meeting participant enrollment targets.
  • Documenting recruiting efforts and outreach progress.
  • Facilitate conversations with potential participants through both inbound and outbound calls sometimes serving as their first introduction to research.
  • Participate in all mandatory compliance, patient engagement and other training programs, seek guidance for compliance-related concerns and adhere to all applicable laws, regulations and EmVenio policies and procedures.
  • Maintain positive control of all PHI information.
  • Participate in required training and education programs.
  • Ensure adherence to clinical trial protocols and supports the clinical trials team in ensuring that trials are conducted and comply with all regulatory, state, national and internationally accepted guidelines for Good Clinical Practice (ICH GCP).
  • Aids in educating EmVenio Research staff and participants regarding the designated clinical trial and procedures and relevant investigations associated with the designated clinical trial and to raise the profile of research throughout the EmVenio Research.

Pay

The typical base pay range for this role is USD $56,160 - $76,960 per year. Individual base pay depends on various factors, in addition to primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience, skills and other market-based factors.

Benefits

  • Medical
  • Dental
  • Vision
  • 401(k)
  • Company Paid Short Term Disability
  • Flexible Spending Account (FSA)
  • Health Savings Account (HSA)
  • Paid Time Off
  • Voluntary Benefits

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