Job Description

The Clinical Research Coordinator, works within a network of 10 locations and 17 PIs to conduct clinical trials in rheumatology. Responsible for independently conducting observational, biorepository, device, and pharmaceutical interventions trials at one location. Collaborate with peers, physicians, sponsors, and administrative staff to ensure proper conduct of the protocol in compliance with all FDA regulations, IRB requirements, GCP guidelines, and Standard Operating Procedures.

We offer the following benefits to support you: Bonuses, Productivity Merits, 401K Contributions, Life Insurance, Health/Dental/Vision Insurance, Disability Insurance, Paid Time Off (Up to 4 weeks), Tuition Assistance, Professional Certifications & Membership.

RESPONSIBILITIES:

• Performs clinical duties as required, including but not limited to medical histories, consenting, electrocardiograms, pulmonary function tests, psychological assessments, subcutaneous injections, vital signs, phlebotomy, specimen processing, laboratory testing, pharmacy dispensation, patient education, adverse event reporting.

• Performs administrative duties as required, including but not limited to data entry, scheduling, filing, inventory, team meetings. Work directly with study sponsors and sponsor representatives with onsite visits, data verification, and query resolutions. Participates in ongoing training initiatives for staff and providers.

• Provides ongoing feedback and actively participates in improving organizational performance.

• Responsible for up to 10 studies and expected to perform 20-40 visits a month.

• Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients.

• Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.

• The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, hosting recruitment breakfasts, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach.

• Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate.

• Responsible for chain of custody and accurate accountability of investigation product and devices.

• Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
• Informed Consent

• Obtaining patient medical history and medication lists

• Phlebotomy and basic laboratory tests

• Processing & shipping labs for central and local labs

• Patient education and training

• ECG

• Administer questionnaires and assessments

• Vital signs

• Collect information for adverse event reporting

• Assist with joint counts and other efficacy assessments

• Data Entry and Query Resolution

• Study drug administration, including injections

• Tracking study supply inventory and reordering when necessary

• Schedule patient visits in appropriate electronic systems

• Documenting all patient visits and communications in progress notes

• Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
• Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
• Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
• Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
• Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
• Serves as a liaison to all physicians, AARA employees, and third party vendors.
• Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
• Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
• Ensures that primary referring physicians receive timely progress notes on the patient’s diagnosis and treatment.
• May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
• Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
• Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
• Maintaining office supply inventory while keeping an organized office space.
• Travel as necessary for Investigator Meetings and other AARR sites.

Qualifications:

• Bachelor’s Degree
• 1 year experience as a clinical research coordinator

• Individual must have or be working towards obtaining Clinical Research Coordinator Certification (CRCC).

• Must have in-depth knowledge of medical procedures and clinical terminology

• CPR certified

• Possess strong organizational skills

• Ability to develop and maintain strong professional relationships with all providers and research subjects

• Maintains confidentiality of patient and study information

• Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations

• Understands and supports specific State regulations governing clinical research

• Excellent verbal and written communication skills

• Ability to lift 20 pounds

• Willing and able to travel for Investigator Meetings and other AARR sites

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 10 hour shift

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
All employee are required to be vaccinated for COVID-19 and wear masks in the clinic while seeing patients.

Application Question(s):

• AARA requires an annual flu vaccine, and COVID-19 vaccine for all staff as a company-wide policy. Are you comfortable complying with this policy?
• AARA is a drug free, non smoking workplace. Are you comfortable with complying with this company policy?
• What is your desirable rate of pay?

Education:

• Associate (Required)

Experience:

• Clinical research: 1 year (Required)

Work Location: In person

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