Clinical Research Coordinator

Professional Case Management•Garden City, MI

4d•$54,080 - $74,880•Onsite

About The Position

Put your talents to work at PCM! Whether you work in our Home Care, Clinical Research, Impairments, or Catastrophic Care division, you will support our mission to deliver care and other services that enhance the quality of life of our clients. 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 provide technical and administrative support to your assigned clinical operations team in the field as well as direct patient care of research study participants. You work with a high attention to detail, reviewing documentation, coordinating clinical study project details, and maintaining data systems - all with a sense of urgency aligned with that of our customers. The position will involve the conduct of trial coordinator activities for EmVenio Research’ decentralized network. This will include assessing and following trial participants along with other trial protocol-related activities. In this role the CRC is accountable for the regulatory compliance and performance of assigned mobile clinics and clinician teams conducting decentralized trials as well as patient engagement, and screening. Additional focus will be on timely and accurate EDC data entry and query resolution.

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.
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.

Nice To Haves

Phlebotomy and ECGs experience not required, but preferred.
ACRP or SOCRA Clinical Research Certification (Preferred), Clinical Research Training Certification (Preferred)

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.