Clinical Research Coordinator, Boardman OH

POSITION SUMMARY

The Clinical Research Coordinator (CRC) is responsible for a variety of activities in support of clinical research studies. The CRC works closely with and carries out the directives of the Director of Clinical Research in all aspects of the care and treatment of clinical research subjects in compliance with study protocols throughout the research study. The CRC is responsible for his/her assigned portfolio of studies as it relates to but is not limited to, the following areas: regulatory requirements; informed consent; recruitment; accurate and timely completion of case report forms, patient visits (paper and electronic); data entry; laboratory; test article; adverse event reporting; and study close out. The CRC is required to have knowledge of protocol design and Good Clinical Practices (GCP) as set forth by the Federal Regulations and International Conference of Harmonization (ICH) Guidelines for the protection of human subjects and the conduct of clinical research required. Knowledge of the International Air Transport Association (IATA) regulations for the transportation of Dangerous Goods is also necessary. Under the direction of the General Manager, the CRC will help ensure protocol compliance, Investigational Article accountability, and proper follow-up during the clinical trial.

TYPICAL PHYSICAL DEMANDS: Physically capable of lifting, moving, or transporting supplies, medical records, and equipment within reasonable weight limits. Physically capable of reading and reviewing handwritten chart notations. Physically capable of bending, sitting, or standing for extended periods of time, reaching, and climbing to retrieve or store medical records. Physically capable of manually entering data into an electronic database using a keyboard. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

TYPICAL WORK CONDITIONS: Fast-paced clinical research center environment. Must be able to adjust and adapt to changing conditions.

QUALIFICATIONS, REQUIREMENTS and EDUCATION: Minimum: High School Diploma. Preferred: Associate degree in a medical-related field and clinical research experience. We prefer the candidate to sit for and successfully obtain CCRC after two years of clinical research coordinator experience. Travel within the USA to attend Investigator meetings for new clinical trials may be required.

ESSENTIAL SKILLS:

• Maintain the highest level of professional conduct in the presence of investigators, subjects, research staff, sponsors, etc.
• Able to perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study-specific protocols
• Computer skills with the capability of using clinical trial databases, electronic data capture, Microsoft Word Office
• Ability to communicate clearly using excellent verbal and written communications skills
• Possess exceptional organizational and prioritization skills as demonstrated by planning objectives and strategies to ensure that the process/requirements for the flow of clinical research information are optimized; such as charting is completed accurately and thoroughly and subject binder provided to Data Entry for EDC processing within 48 hours of the patient visit.
• Ability to problem-solve, prioritize quickly and accurately, and multi-task to facilitate workflow
• Utilize negotiation skills to achieve expected results.
• Ability to work independently in a fast-paced environment, as well as work collaboratively as a team
• Possess and utilize excellent interpersonal skills with patients, staff, and others
• Meticulous and detail-oriented
• Ability to perform ECG, Phlebotomy, Urinary Pregnancy Test
• Ensure the proper collection, processing, and shipment of biospecimens (e.g., centrifuge, freezing, refrigeration.

DUTIES AND RESPONSIBILITIES:

Regulatory:

• Maintains a copy of all required Regulatory Documents for the assigned portfolio of studies
• Assists DSO and/or DCR in preparing for IRB submissions, protocol revisions, periodic or final reports, and submitting timely and accurate regulatory documents to sponsors, as needed.
• Maintains Master File with copies of all IRB communications for assigned portfolio of studies
• Supports the safety of clinical research participants
• Adhere to Good Clinical Practices and the study protocols
• Any other duty which may be assigned to ensure all regulatory documentation occurs in a timely and thorough manner.

Clinical Trial Process:

• Assists in facilitating and coordinating the daily clinical trial activities
• Understands the details of each assigned portfolio of studies
• Reviews and comprehends each protocol of the assigned portfolio of studies, including study proceedings and timeliness, inclusion and exclusion criteria, confidentiality and privacy protections
• Participates in the pre-screening of potential research participants to determine their initial eligibility and interest in a research study and adhere to important guidelines to protect the privacy of the patients
• Assists in screening, recruiting, and enrolling research participants
• Participates in the Informed Consent process by communicating clearly and openly with potential study patients about; protocols open to enrollment, explain the purpose, duration, risk/benefits of the study, and obtains all required signatures
• Possesses a thorough knowledge of the Informed Consent process, as well as a thorough understanding of the study protocol (s) in order to answer all questions pertaining to the study posed during the Informed Consent process.
• Ensures the current approved Informed Consent is signed before Subjects are screened and enrolled in a clinical study
• Provides research participants with a copy of their signed Informed Consent.
• Ensures participant’s primary care physician receives the notification of the participant’s participation in a study if requested by the patient
• Provides the receptionist with the target date and window for scheduling patient follow-up visits
• Ensures adherence to protocol requirements
• Assists the Director of Clinical Research with requirements of patient visits per study protocol, such as: obtaining vital signs, documenting assessment of patient response to Investigational Product and evaluation of Adverse Events (AEs); retrieving Investigational Article and documenting Subject compliance with the required dosage
• Dispense Investigational Article in a professional and accountable manner following protocol requirements
• Knowledgeable of the storage/temperature requirements for all assigned study medications stored on site
• Maintains Investigational Product Dispensing Log of assigned clinical trial studies by correctly and completely recording drug distribution at the time it is dispensed; and the return of drug by subjects within 24 hours as part of visit completion requirements
• Continually review concomitant medications
• Ensures appropriate specimen collection, processing, and shipment per study protocol
• Communicates abnormal laboratory values to appropriate persons in a timely manner.
• Communicates regularly with Investigators about study progress and issues
• Records all Adverse Events (AEs) reported by study participants
• Reports all SAEs to Investigator, Sponsor’s Clinical Research Associates (CRA), primary care physician, and IRB
• Administers questionnaires/diaries per protocol

Data Entry

• Helps ensure that all required documentation is complete and appropriately filed for Sponsor Audits and/or FDA Inspections
• Ensures all trial documentation (regulatory, IRB Communications, Subject, and Investigational Article logs, etc.) is properly filed at trial closeout.
• Accurately completes and maintains Case Review Forms (CRFs) (paper or electronic) per FDA guidelines and ensures all forms have been forwarded to the Sponsor
• Maintains study source documents in the subject binder (e.g., medical history, laboratory reports, ECG, etc.)
• Documents are written and verbal communication with study contacts (e.g., research participant, sponsor, laboratory, etc.)
• Completes and submits case report forms on as close to a “real-time basis” as possible, but no greater than 48 hours after the patient visit
• Ensures that all study tasks information is completed so that invoices for study payments can be made in a timely and complete fashion
• Stores all files in a permanent, dry, and safe location
• Prepares for clinical trial monitor site visits; assists and provides requested information during the visit to facilitate a pleasant and optimal experience for the monitor
• Assists Data Entry Specialists in addressing queries and clarifications as needed
• Maintain a cooperative, helpful and pleasant affect, creating and/or contributing to an atmosphere of collaboration and team cohesiveness

Other:

• Works with study monitors at site visits to resolve any outstanding issues or queries before the end of the site visit
• For an assigned portfolio of studies, works toward resolving all unresolved flagged issues within one week of the site visit and report completion status or progress toward a resolution to the Director of Site Operations. It is expected that all outstanding issues will be resolved prior to the next monitor visit.
• Completes Continuing Education/In-service Education Requirements in the designated timeframe
• Maintains current training in the following areas: OSHA training regarding Bloodborne Pathogens; International Air and Transportation Association (IATA) training for routine packaging, labeling, and transporting of biological materials; Basic Life Support (BLS) and AED training
• Adheres to ICTC Policies and Procedures, Employee Guidebook, and Standard Operating Procedures
• Consistently demonstrates support for compliance in the performance of job duties and responsibilities by developing and maintaining knowledge of and performing job functions in compliance with rules, regulations, policies, and statutes that affect the CRC job function.
• Performs additional duties as assigned by the Director of Clinical Research and/or Director of Site Operations to ensure the continuing success of ICTC
• Assists CRSA-II with biospecimen processing and shipments when necessitated by heavy processing volumes or as directed
• Assists other staff as needed or directed
• Assists in the day-to-day operations, as needed and as assigned
• Provide the Director of Site Operations with a report of CRC activities, outstanding issues, assignment progress and/or completion, prep for upcoming monitoring visits, etc.