Clinical Research Coordinator I

Meharry Medical College; United States; On-site; USD 55,000 - 75,000; Full time

Job summary

Meharry Medical College seeks a Clinical Research Coordinator I to manage specimen collection, processing, and shipment while ensuring compliance with IRB, FDA, HIPAA and GCP guidelines. The role includes budgeting, data management, and coordination with physicians and nurses in a laboratory setting.

The CRC I will perform venipunctures, vital signs, and protocol procedures, maintain records, and assist with IRB submissions. Strong team orientation and attention to biosafety are essential.

Qualifications

• Graduated from an accredited discipline specific program and licensed as phlebotomist/lab technician in Tennessee.
• Bachelor's degree in a healthcare related field required.
• 60 months experience in patient care or research setting (clinical research preferred).
• Completion of Human Subjects Protection & Good Clinical Practice (GCP) training within 30 days of hire.
• Current Basic Life Support (BLS) certification.

Responsibilities

• Assess eligibility of potential subjects through interviews and medical records reviews.
• Maintain study activity records including case report forms and regulatory documents.
• Assist with budgets, revenue, expenses, invoices, and related accounting.
• Review, analyzes and negotiates lab budgets and contracts with sponsors under PI guidance.
• Perform protocol procedures e.g., vital signs, venipunctures, and subject interviews.
• Direct specimen requisition, collection, labeling, and shipment.
• Monitor activities for compliance with protocols and regulatory polices.
• Schedule subjects for appointments and procedures as required.
• Prepare IRB submissions and manage communications with IRB.

Skills

Clinical research

IRB compliance

Regulatory knowledge

Phlebotomy

Budgeting & accounting

Data entry accuracy

Team oriented

Laboratory safety

Education

Bachelor's degree in healthcare related field

Licensed phlebotomist (Tennessee)

GCP / Good Clinical Practice training

Tools

REDCap

LIMS

EMR systems

Job description

The Clinical Research Coordinator I (CRC I) will be responsible for specimen collection, processing, shipping, and tracking for T4C initiative.

The CRC I will be responsible for inventory and keeping the lab clean and orderly at all times. He/she will use lab equipment and supplies according to standard biosafety guidelines, study protocols and Meharry regulations. Independently able to access regulations governing the protection of human subjects- IRB, FDA, OHRP, GCP/ICH and HIPAA guidelines and apply regulations in practice.

• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
• Maintain required records of study activity including case report forms, consenting research subjects, or regulatory forms.
• Performs standard accounting functions, monitors and reviews accounting and related system reports for accuracy and completeness; prepares and reviews budget, revenue, expenses, invoices, and other accounting documents.
• Assist with reviews, analyzes and negotiates lab research budgets and contracts with sponsors under the direction of the Principal Investigator and Associate Director.
• Performs specific protocol procedures such as interviewing subjects, taking vital signs, and performing venipunctures.
• Direct the requisition, collection, labeling, or shipment of specimens.
• Monitors study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
• Schedules subjects for appointments and procedures as required by study protocols.
• Informs patients or caregivers about study aspects and outcomes to be expected.
• Assists with preparing IRB submissions, protocol revisions, and renewals as needed, and maintains copies of all IRB communications delegated by the Principal Investigator.
• Performs other related duties as assigned.

• Must possess a good working knowledge of basic clinical research practices.
• Must be proficient with personal computer.
• Ability to utilize keen judgment in evaluating information.
• Ability to numerically and accurately enter and calculate test results in an electronic database.
• Ability to work in a stressful environment.
• Must be team oriented.
• Accepts constructive criticism without issues.

• Knowledge of biospecimen collection, processing, labeling, aliquoting, storage, and shipment Knowledge of biobanking principles and specimen chain-of-custody procedures Familiarity with clinical laboratory operations and quality assurance practices Understanding of human subject protection regulations, HIPAA, and FDA regulations Familiarity with Laboratory Information Management Systems (LIMS) Experience handling blood, urine, saliva, and other human biological specimens Knowledge of centrifugation, pipetting, specimen processing, freezer inventory management, and cold-chain requirements

• Graduated from an accredited discipline specific program and licensed as phlebotomist/lab technician in the state of Tennessee.
• 60 months experience in a patient care or research setting required (clinical research experience preferred).
• A Bachelor's degree in a healthcare related field.
• Licensed phlebotomist preferred.

• One (1) to two (2) years of experience in clinical research, translational research, or biomedical laboratory research.
• Experience processing and handling human biological specimens.
• Experience supporting observational studies, clinical trials, or biobank research.
• Experience with specimen shipping in accordance with IATA regulations.
• Experience with freezer inventory management and temperature monitoring systems.
• Experience with REDCap, electronic medical records (EMR), CTMS, or laboratory information systems.

• Current Basic Life Support (BLS) certification (or ability to obtain within 90 days of hire).
• Completion of Human Subjects Protection & Good Clinical Practice (GCP) training within 30 days of hire.
• Completion of required institutional compliance training (e.g., HIPAA, OSHA, Bloodborne Pathogens).

• IATA Dangerous Goods Shipping Certification
• Current CPR/BLS certification
• Venipuncture certification or documented competency in specimen collection

Equal Employment Opportunity Statement Meharry Medical College complies with Title IX and is an affirmative action employer. Candidates will be considered for employment without discrimination for an non-merit reason such as race, color, national origin, sex, religion, age, handicap or veteran status.

***This position is funded through a grant and is contingent upon the availability of grant funding. Employment in this role is expected to continue for the duration of the grant period, subject to satisfactory performance and the continued availability of funding. While the organization intends to maintain this position for the full grant term, employment may end or be modified if grant funding is reduced, discontinued, or otherwise unavailable.

About Meharry Meharry Medical College was founded just 11 years after the end of the Civil War with the mission of educating African Americans to serve the underserved. Today, the nation's largest private, historically black academic health sciences center has trained thousands of health care professionals. Three out of every four Meharrians return to urban or rural communities to serve others by providing medical or dental services. Our faith-based roots within the United Methodist Church inspire us to respect and serve all. Our standards are high within an educational environment that is nurturing. We believe that health equity is key to alleviating suffering. Whether our graduates are physicians, dentists, scientists, professors or public health professionals, the Meharry experience equips them to affect the world as a force for change led by our motto: "Worship of God Through Service to Mankind." Mission Meharry Medical College is a global academic health sciences center advancing health equity through innovative research, transformative education, exceptional and compassionate health services and policy-influencing thought leadership. True to its legacy, Meharry empowers diverse populations to improve the well-being of humankind. Core Values Meharry Medical College is a community of scholars and learners committed to excellence Accountability with transparency Equity with inclusion Respect with collegiality Service with compassion Integrity without exception Equal Employment Opportunity Statement Meharry Medical College complies with Title IX and is an affirmative action employer. Candidates will be considered for employment without discrimination for an non-merit reason such as race, color, national origin, sex, religion, age, handicap or veteran status.

Contact For questions regarding employment, please contact 615-327-6336 or [e-mail].