Under the direction and supervision of the Director of Clinical Operations, Manager of Clinical Operations and Principal Investigator, the Clinical Research Coordinator I (CRC I) is responsible for providing support for clinical research protocols. The CRC I facilitates all implementation phases of new clinical research studies as well as the ongoing coordination and maintenance of open and closed studies. The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. The position works closely with the Principal Investigator, members of the department, study sponsors and monitors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of all ongoing clinical studies. This individual will interact with subjects, clinic and research staff, laboratory staff, radiology staff and any other medical professionals associated with our clinical research protocols.
The Clinical Research Coordinator I fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials related to all therapeutic areas represented throughout MemorialCare. In doing so, the Clinical Research Coordinator I is responsible for coordinating trial participation of study volunteers with the trial’s protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator I is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. After hours support and coverage may be needed to adequately meet the needs of the research subject and/or adhere to the protocol recruitments.
Essential Functions and Responsibilities of the Job
Under direct supervision of the Director of Clinical Operations, Manager of Clinical Operations and principal investigator, the CRC I is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials.
Collaborates with study investigator in determining eligibility of potential participants in clinical trials.
Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol.
Ensures research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide participants’ education regarding medication administration. Maintains investigational drug accountability, when needed, in cases where the Research Pharmacy is not maintaining that responsibility.
In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
Maintains current and accurate documentation in the regulatory binder(s) as required by regulations and sponsors.
Participates in required training and education programs.
Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in the after-hours support and coverage schedule, if necessary.
Be at work and be on time.
Interacts in a positive and constructive manner.
Follows company policies, procedures and directives.
Essential Job Outcomes
Support clinical research activities for multiple research projects.
Recruit subjects for participation in studies, facilitate patient care, prepare the case report form (CRF), submit CRFs and other data to the sponsor as necessary and facilitate study close-out.
Assemble lab kits and other supplies in preparation to obtain required biospecimen samples and transport to appropriate laboratories for processing; ship samples externally according to IATA requirements.
Provide support (including administrative/clerical) and information to subjects, staff, and external sources related to current research projects.
Maintain scheduling of pre-study testing, treatments, outside labs, scans, biopsies, and other tests for all clinical research visits.
Attend meetings and conferences related to research activities.
Maintain appropriate records of clinical activities.
Support clinical research billing reconciliation activities.
Support the identification of research subjects as they utilize services throughout MemorialCare. This will include flagging/notifying registration and/or appropriate patient accounts personnel to foster proper research coding and billing pursuant to research billing practices.
Demonstrate the ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through.
Understand applicable regulations and implications for trial participation to include knowledge of FDA regulations and GCP guidelines.
Demonstrate strong written and verbal communication skills. Ability to establish and maintain positive study participant, project team member and internal relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner.
Escalate issues in a timely manner and communicate outcomes effectively across impacted team members.
Demonstrate ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making.
Maintain working knowledge of current protocols and internal SOPs.
Provide excellent customer service experience for patients; responding to patient needs in a timely manner.
Provide investigators with guidance regarding protocol requirements.
Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data Safety Review Committee.
Assist with preparation and conduct of audits, inspections, and monitoring visits from regulatory agencies and sponsors.
Attend continuing education and training opportunities relevant to job duties.
Other duties as assigned.
Minimum of two (2) years of clinical research experience required.
Knowledge of clinical trial federal, state and local regulation requirements preferred.
Excellent interpersonal and communication skills required.
Ability to read and understand clinical trial protocols required.
Strong data management skills and attention to detail required.
Familiarity with medical terminology/environment required.
Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) required.
Must maintain a valid driver’s license and automobile insurance as travel to physician offices and health system locations is required for departmental specific job duties.
Associates degree or equivalent education required.
Bachelor’s degree in relevant field preferred.
Research certification (e.g. ACRP, SoCRA or equivalent) preferred.