Lead Clinical Research Coordinator-Memphis, TN

What We Do

Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.

Who We Are

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.

Position Overview

The Lead CRC is responsible for overseeing the day-to-day activities at the site under the direction of the Region Manager. The Lead CRC is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials. The Lead CRC will also carry a full study load.

What You'll Be Working On

Duties include but not limited to:

Site Support Responsibilities:

Primary point of contact for the site

Supports Key Sponsors and CROs

Manages some of the sites most challenging therapeutic areas and study designs

Able to monitor and mentor all levels of CRCs to ensure complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities

Assist Region Manager and Operational Compliance and Quality Assurance Departments with all Care Quality and FDA audits

Develops and maintains CAPAs, when needed, with approvals from the Regional Site Manager

Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input

Study Preparation:

•        Ability to understand and follow institutional SOPs

•        Collaborate with PI to review and assess protocol (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.

•        Work closely with Central Teams to ensure that all training and study requirements are met prior to trial conduct

•        Discuss study medication, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff

•        Assist with planning and creation of appropriate recruitment materials

•        Assist in the development of recruitment plan and obtain a listing of potential candidates to contact from the subject database

•        Actively work with the recruitment team in calling and recruiting subjects

•        Attend Investigator meetings.

•        Coordinate and attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives and report summary to the Region Manager if they are not in attendance

•        Assist in the creation or review of sponsor-provided protocol specific source documents

•        Determine facility, equipment and outsource vendor requirements and availability

•        Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access, and passwords)

•        Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits

•        Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation

•        Work with Region Manager to identify and communicate staff needs

•        Ensure there are adequate supplies and equipment on site

Study Management:

•        Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines

•        Maintain organized files for blank source documents, patient charts, CRFs, and supplies

•        Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document accountability log and patient records. Temperature monitoring and compliance of IP storage conditions.

•        Collect and evaluate concomitant medication

•        Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings

•        Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials

•        Communicate sponsor updates, patient-specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of the Care Access team in an ongoing fashion

•        Maintain effective relationships with study participants and other Care Access personnel

•        Interact in a positive, professional manner with patients, sponsor representatives, investigators, and Care Access personnel and management

•        Communicate clearly verbally and in writing

•        Accept accountability for actions and function independently

Study Visit Conduct:

•        Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling a screening appointment

•        Collect and review medical records against study Inclusion/Exclusion criteria

•        Obtain informed consent per Care Access SOP

•        Complete delegated visit procedures and ensure proper specimen collection, processing, and shipment in accordance with the protocol

•        Review laboratory results, ECGs, and other test results (e.g. MRIs) for completeness and alert values ensuring investigator review in a timely fashion

•        Record adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify the Principal Investigator, Sponsor, and Regulatory team following all applicable guidelines

•        Schedule participants within visit windows, notify personnel as needed for procedures, and integrate visits with existing schedules to maximize efficient workflow and positive participant experience

Documentation:

•        ALCOA-C: Record data legibly, in real-time on source documents; note additional information that may assist with the causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP

•        Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion

•        Accurately transcribe data to eCRF. Resolve data management queries and correct source data timely

•        Enter all Quality issues into QMS and report protocol deviations to sponsor

•        Work closely with Regulatory Team to ensure all documents are uploaded into eReg system

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

Physical and Travel Requirements

·       This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role.

·       Ability to work evenings and weekends as needed

·       Must have access to reliable transportation

What You Bring

Knowledge, Skills, and Abilities:

Excellent working knowledge of medical and research terminology

Excellent working knowledge of federal regulations, good clinical practices (GCP)

Ability and willingness to mentor and train site staff

Ability to communicate and work effectively with a diverse team of professionals

Excellent organization, prioritization, and leadership skills with strong attention to detail

Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel

Critical thinker and problem solver

Excellent interpersonal skills, detail-oriented and meticulous

Friendly, outgoing personality with the ability to maintain a positive attitude under pressure

High level of self-motivation and energy

Excellent professional writing and communication skills

Ability to work independently in a fast-paced environment with minimal supervision and as a team player working together towards common goals

Certifications/Licenses, Education, and Experience:

- Bachelor’s Degree or equivalent professional experience 

-Research Professional Certification preferred

-A minimum of 5 years of Clinical Research Coordinator experience

Benefits (US Full-Time Employees Only)

●      PTO/vacation days, sick days, holidays.

●      100% paid medical, dental, and vision Insurance. 75% for dependents.

●      HSA plan

●      Short-term disability, long-term disability, and life Insurance.

●      Culture of growth and equality

●      401k retirement plan

Diversity & Inclusion

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the

physicians and caring for patients.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

Employment Statement

Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.