Clinical Research Coordinator

Clinical Research Coordinator

Requirements

• 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
• 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
• Ability to successfully complete EmVenio Research clinical training program
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
• Must have strong interpersonal skills to be able to interact with multiple people on many different levels

Responsibilities

• Complete study tasks as outlined by trial protocol
• Ensures documentation is accurate according to EmVenio guidelines and protocols is required
• 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
• Certain assignments may require provider to perform ECGs, draw blood (Phlebotomy), process and ship lab specimen, etc.
• Consults with the Site Manager and virtual Clinical Research Coordinator to ensure compliance with guidelines
• Reviews the medical and social history of members
• Assist in building the community research site network and developing relationships within that community
• Participates 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
• Facilitates conversations with potential participants through both inbound and outbound calls sometimes serving as their first introduction to research
• Participates in all mandatory compliance, patient engagement and other training programs, seeks guidance for compliance-related concerns and adheres to all applicable laws, regulations and EmVenio policies and procedures
• Maintains positive control of all PHI information
• Participates in required training and education programs
• Ensures 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)
• Ensures timely and accurate data collection and completion of case report forms relevant to clinical trials or research projects
• Assists in liaising with monitors of clinical trials and available to monitor and/or audit when required, with full patient documentation available
• Assists 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
• Any other duties needed to help drive EmVenio’s purpose, fulfill our mission, and abide by our core values.

Preferred Qualifications

• Two (2) years research experience strongly preferred
• Phelbotomy and ECGs experience not required, but preferred
• ACRP or SOCRA Clinical Research Certification (Preferred)
• Clinical Research Training Certification (Preferred)