This role will have the special objectives of supporting PCC site selection, qualification, and recommendation activities, as well as execute initiation, training, and activation procedures for assigned clinical sites in his/her territory. As necessary, this role will participate in the orientation and training of appropriate site personnel for the roles delegated by the Principal Investigator and ensure all essential records are obtained prior to enrollment of the first subject, including, but not limited to preparing IRB submissions and securing IRB approval for investigators, study personnel, protocol amendments, and recruitment materials. As a member of the Clinical Affairs team, with members based in Novi, Michigan, and several remote locations in the United States, this role will facilitate unity as the team aligns individual contributions toward common objectives and foster a collaborative culture that is creative, cooperative, can-do, energetic, fun, and solution seeking
This role will make key contributions to the integrity, quality, and success of the company’s clinical case and data collection programs and ongoing product development efforts. The primary responsibilities of this role will be for the hands-on encouragement, technical support, management, supervision, and monitoring of clinical prospective case collection sites.
- Collaborates with internal leadership, clinical site staff, and site investigators to drive successful execution of engineering test projects, clinical trials, and prospective case collection protocols
- Proactively mitigates risks to meet established timelines and to ensure fulfillment of company recruitment / enrollment objectives set by Delphinus for clinical sites
- Establishes a positive, cooperative, open, and supportive relationship with clinical site staff and site investigators, adapting to the site’s culture, and integrates as if a part of the “site family”
- Assists in site start-up activities including collection and review of essential regulatory documents to ensure sites are qualified for the study and there is sufficient documentation to support it
- Maintains frequent communication and regular face-to-face contact with investigators and clinical site staff to ensure GCP/ICH/protocol compliance, and maximize subject accrual
- Communicates project-specific information to/from trial sites, documents communication, and escalates serious issues to internal leadership and other appropriate persons in a timely manner
- Works constructively with internal leadership, clinical site staff, and site investigators to prevent, identify, address and resolve issues, before they are escalated to higher levels of administration
- Collaborates, communicates, and cooperates with other CRAs and members of the Clinical Affairs team, supporting them as needed, sharing best practices and accepting their feedback
- Takes the initiative to develop any necessary aids to allow sites to proceed expeditiously (e.g. newsletters, flow charts) and advance the program overall (metrics, monitoring tools)
- Independently plans, schedules, and performs monitoring visits, including site selection, site qualification, site initiation, site activation, routine monitoring, source verification, image data backup, image quality audit, and site closure visits.
- Conducts weekly internal meetings with site investigators and coordinators to discuss monitoring findings, action items, and site progress, as well as exchange pertinent information
- Clearly documents all relevant site interactions, findings, action items, and progress in monthly reports and post-visit follow-up letters, according to Standard Operating Procedures
- Participates in bi-monthly project meetings, by phone or video conference, with representatives from all sites in attendance, as well as other CRAs and Delphinus Clinical Affairs management
- Ensures all personnel at study sites are appropriately informed and trained, if necessary, before activation. This will include information and training on: protocol, human subjects protection, GCP, ICH, AE reporting, case report forms, EDC, patient information sheets, recruitment strategies, informed consent, IRB requirements, data storage and accountability, source documentation, investigational device operation and device maintenance
- Ensures timely query resolution through support of clinical sites
- Reviews safety reports and ensures the site is reporting adverse events appropriately and in a timely manner according to IRB requirements and Standard Operating Procedures
- Maintains ICH-GCP documentation for trial sites as stipulated
- Assists with electronic data capture (EDC) system development, validation, verification, and implementation of eCRF processes, as requested by Clinical Affairs management
- Assists in the maintenance of standard operating procedures (SOPs) for the clinical research program, performing review and assisting with revision of procedures, as needed
- Provides assistance with central and local IRB submissions, central and local IRB status reports, as well as central and local IRB modifications
- Assists with preparation of required regulatory submissions to FDA, as requested
- Assists clinical sites with IRB/IEC submissions and ensures collection of required essential documents throughout the conduct of study
- Presents at and participates in Investigator Meetings, Clinical Advisory Board, trainings, professional conferences, and other clinical activities, as requested
- Acts as mentor and co-monitor with less senior CRAs and Clinical Program Coordinator to ensure high quality and performance
- Takes an active role in project team activities including interim reports, image data collection, case organization, and preparation for reader studies
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to read and interpret documents such as protocols, standard operating procedures, consent forms, and case report forms. Ability to write routine reports and correspondence with clinical sites, institutional review boards, and other Clinical Affairs personnel. Ability to speak effectively before groups of customers or employees of the organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
High School Diploma required, Bachelor’s degree preferred; as well as the following:
- Knowledge of FDA PMA approval process, medical terminology and clinical trial requirements for NSR medical imaging devices
- Excellent understanding of ICH GCP and monitoring practices with a track record for ensuring high quality data and performing effective site management while maintaining a positive and cooperative working relationship with site staff and investigators
- Familiarity with the breast care pathway, breast cancer screening and diagnosis, radiologic imaging, mammography, tomosynthesis, ultrasound, MRI, biopsy, and pathology
- Professional demeanor and appearance that reflects competency
- Must have high degree of accuracy and attention to detail
- At least 5 years of clinical research experience in the healthcare, biotechnology, medical device, and/or pharmaceutical industry.
- At least 2 years of experience monitoring clinical trials
- At least 1 year working in a breast imaging facility or on a mammography related project
- Experience with customer service practices, working with physician investigators and staff
To perform this job successfully, an individual should have experience in the use of MS Office (Word, Excel, and PowerPoint), MediData Rave Electronic Data Capture, ClinicalTrials.gov, online IRB submission applications, HIS/RIS, PACS and hospital worklist functionality as well as experience using electronic data capture for data entry, query resolution, source verification, monitoring and progress reporting.
Knowledge, Skills and Other Abilities:
- Organized, self-motivated, and able to produce high quality work.
- Ability to independently meet critical deadlines as well as work cooperatively as part of a multi-disciplinary team to meet larger objectives
- Possesses excellent writing, verbal communication, interpersonal and diplomacy skills, with the character of a strong leader
- Ability to research peer reviewed publications and provide a summary of results and conclusions
- Ability to perform work accurately and thoroughly
- Ability to communicate effectively with others using American English
- Ability to work in a fast paced environment with minimal direction or supervision and multi-task in a high volume subject enrollment setting
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, use hands, and talk or hear. The employee is frequently required to stand, walk, and reach with hands and arms. The employee is occasionally required to climb or balance, and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 10 pounds. They also occasionally move objects weighing up to 20 lbs., and sometimes, but rarely, up to 50 lbs. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to see color.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles, and risk of electrical shock. The noise level in the work environment is usually mild to moderate. This position requires a significant amount of desk work and time performing tasks on a computer.
In the clinical environment, while performing site visits at hospitals and breast cancer treatment centers, the employee may be exposed to communicable diseases and chemicals used for sanitation, sterilization, and/or infection control. The risk of exposure to radiation, chemo-toxic compounds and illness will be less than that of clinical staff, as this position does not involve direct patient care or contact, however the risk is not zero. Some facilities will require immunizations and infectious disease testing before access to patient care areas can be granted.
Up to 75% domestic US travel, as necessary, within assigned regional territory, but sometimes to other territories, to keep up with monitoring and site support responsibilities, as well as back-up other CRAs at their regional sites, as needed.Apply