Clinical Research Coordinator (On-Site)

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), you will provide technical and administrative support to your assigned clinical operations site teams at one or multiple of our permanent community Mobile Research Units (MRU), or occasionally through home visits management. 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 CRC is responsible for ensuring participant safety, data integrity, data quality, and maintenance of protocol standards in various therapeutic areas. As a CRC, you will assist various virtual Principal Investigators (vPIs), through delegated authority, with conducting clinical trials per federal, state, and institutional guidelines, while learning the responsibilities during 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.
 

• Study coordination:
  • Coordinate, with supervision, assigned clinical trials including start up, vendor management, subject recruitment, source development 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, providing all close out reports.
  • Maintains CTMS, eISF, participant scheduling management, QC, and 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.
• 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.
• On-Site and Remote monitoring:
  • Conduct on-site and remote monitoring activities to ensure compliance with study protocols and regulatory requirements, with full patient documentation available.
  • Address and resolve issues identified during remote monitoring visits.
  • Perform clinical duties (e.g. drug preparation and administration, phlebotomy, ECG, lab processing) within scope or delegation if and when on-site.
• Regulatory Compliance:
  • 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, physician assistants, clinical research specialists, leaders, family members, key care givers and any ancillary medical personnel 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.
  • Coordinates team conference calls and distribution of meeting minutes.
• Training and Support:
  • Ensure staff are delegated, trained appropriately and documented.
  • Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
  • Support sites with daily temperature monitoring and inventory management.
  • Regular and reliable attendance with the ability to work after hours/weekends as needed as well as rotating on-call shifts that may include weeknights, weekends, and holidays. 

POSITION QUALIFICATIONS

SKILLS AND ABILITIES
Education:  Associate or Bachelor’s degree or equivalent experience.

Experience:  At least two (2) years or more of recent clinical research experience required. Two (2) years of experience performing phlebotomy, subcutaneous injections, collecting vital signs, ECG, and urine collection preferred.

Computer Skills:  Excellent computer Skills, including Microsoft Office.

Certificates & Licenses:  Current BLS, CITI, GCP, and IATA 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 or outpatient clinic.
• Working knowledge of federal, state, and local laws and regulations governing research.
• Knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
• Ability to provide patient-centric focus.
• 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.
• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged periods of standing, bending, and reaching.
• Must be able to lift up to 50 pounds at times.
• Have the ability to travel regionally by car or nationally by plane, a valid state driver license, proof of adequate automobile insurance coverage for the state of residence.

WORK ENVIRONMENT

Work is performed primarily in a mobile clinical environment, and the incumbent may be exposed to body fluids and infectious diseases. The noise level in the work environment is usually quiet in office settings and moderate in other situations. There is potential that you may be exposed to infectious diseases including but not limited to: Influenza, COVID-19, RSV, etc. Each clinician is equipped with proper PPE and/or supplies to ensure their safety when handling such 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: 1301 N Portland Ave, Oklahoma City, OK 73107 (on-site with potential of some remote work) 

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.