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Clinical Research Coordinator

3 months ago

Garden City, United States EmVenio Research Full time
ABOUT EMVENIO RESEARCH:

EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that benefits all stakeholders. Removing barriers and unlocking doors to innovation reduces risk and time associated with clinical research, while improving ROI.

EmVenio Research offers competitive pay, a comprehensive benefits program and opportunities for learning and career development. We promote a diverse and inclusive workplace, and our team members have a voice in their work through surveys and town halls.

POSITION SUMMARY:
As a Clinical Research Coordinator (CRC), this role will provide technical and administrative support to assigned clinical operations site teams at one or multiple research sites. This position requires a high attention to detail, reviewing documentation, coordinating clinical study project details, including collection of assessments as outlined in the protocol, and entering and maintaining data systems in a timely manner. The CRC is responsible for ensuring participant safety, data integrity, data quality, and maintenance of protocol standards in various therapeutic areas. The CRC assists site teams and Principal Investigators (PIs), through delegated authority, with conducting clinical trials per federal, state, and institutional guidelines. The CRC is involved in all phases of trials from pre-study implementation through study closure.

ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Essential Functions:

Study coordination:
  • Coordinates, with supervision, assigned clinical trials including start up, vendor management, subject recruitment, source design/review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, and providing all close out reports.
  • Maintains CTMS, eISF, participant scheduling management, QC, records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines and frequent review.
  • 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).
  • Helps ensure that all study related activities are complete including returning supplies, returning unused stock of study drug/devices, and confirming that all queries are complete.
  • Performs clinical duties (e.g. drug preparation and administration, phlebotomy, ECG, lab processing) within scope or delegation.
  • Addresses and resolves issues identified during monitoring visits.
  • Understands key timelines, endpoints, required vendors, and patient population for each assigned protocol.
  • Supports sites with daily temperature monitoring and inventory management.
  • Responsible for budget management.
  • Responsible for regular communication and follow up with study participants.
  • Ensures all on-site general and study specific equipment and supplies required for the study are in-stock and in good working order.
Data management:
  • Ensures timely and accurate data collection and completion of case report forms relevant to clinical trials or research projects.
  • Follows ALCOA +C good documentation practices.
  • Regulatory Compliance:
  • Assists Regulatory to create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
  • Reviews new protocols and other materials provided by study sponsors and gives input to the Principal Investigators (PIs), site leadership, and site staff, as applicable, regarding study conduct and research issues in order to resolve financial and clinical feasibility.
  • Assists in conducting quality checks and audits of research studies to check the accuracy, integrity, and consistency of the research studies.
  • Maintains compliance with OSHA HIPPA, GCP and ICH.
Communication and Collaboration:
  • Works collaboratively with internal and external stakeholders such as physicians, nurse practitioners, clinical research assistants, sponsor/CRO monitors, leadership, and site team as appropriate.
  • Performs other duties as assigned including but limited to recruitment and community engagement activities, which may occur after hours and/or on weekends.
  • Regular and reliable attendance with the ability to work after hours/weekends as needed.
POSITION QUALIFICATIONS

SKILLS AND ABILITIES
Education: Bachelor's degree (B. A. / B. S.) from four-year college or university or Medical Assistant, LPN or equivalent.

Experience: Experience in collecting vital signs, performing phlebotomy, lab collection and processing, subcutaneous injections, IV dosing, and ECG required. Five (5) years or more of recent clinical research experience required.

Computer Skills: Excellent computer Skills, including Microsoft Office and ability to obtain knowledge and master all clinical trial database systems

Certificates & Licenses: Current BLS, CITI, GCP,, IATA, and CPR certification preferred

Other Requirements:
  • Excellent verbal and written communication
  • Use of considerable judgment/critical thinking in application of procedures, practices, and policies to work problems, organization, and administration of research site
  • Working knowledge of federal, state, and local laws and regulations governing research per ICH guidelines
  • Knowledge of Good Clinical Practice (GCP) and regulatory guidelines
  • Adaptability/flexibility to react positively to changes in work environment
  • Initiative to improve productivity and quality of work
  • Experience collecting, processing, and shipping lab specimen(s)
  • Ability to plan and organize work in logical and efficient manner
  • Ability to manage time delicate projects to meet deadlines
  • Strong attention to detail
  • Excellent ability to establish and maintain effective working relationships
  • Ability to mentor and train as needed
  • Prolonged periods of standing or sitting at a desk and working on a computer
  • Must be able to lift up to 50 pounds at a time


WORK ENVIRONMENT
Work is performed on site. The noise level in the work environment is usually quiet in office settings and moderate in other situations. This role may be exposed to body fluids and with the potential to be exposed to infectious diseases including but not limited to: Influenza, COVID-19, RSV, etc. Each employee is provided with proper PPE to ensure safety when handling potential subjects and/or samples.

The preceding functions may not be comprehensive in scope regarding work performed by an employee assigned to this position classification. Management reserves the right to add, modify, change or rescind the work assignments of this position. Management also reserves the right to make reasonable accommodations so that a qualified employee(s) can perform the essential functions of the position.

Location: 6625 Inkster Rd Suite 202 Garden City, MI 48135
Amount of Travel Required: up to 10%
Schedule: Monday - Friday 8am - 4:30pm, may vary
Compensation: $28-$38/hour. The actual rate offered will carefully consider a wide range of factors, including your skills, qualifications, experience, and location.