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JOB SUMMARY
The CRC III manages the key global relationships and communication among all internal and external stakeholders involved in a study, keeping all stakeholders informed in a timely and professional manner about the progress and key events with the study. The CRC III is expected to accurately identify issues and creatively resolve problems while correcting processes as needed.
SUPERVISORY RESPONSIBILITIES
ESSENTIAL DUTIES
The candidate will have overall responsibilities for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals, including:
- Develop strong working relationships and maintain effective communication with study team members.
- Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic-related activities.
- Manage multiple concurrent trials
- Assist with mentoring and training study team members
- Completes all protocol-related training
- Perform patient/research participant scheduling
- Collect patient/research participant history
- Collect and maintain source documentation
- Performs data entry and query resolution
- Collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging and laboratory handling manuals, etc.).
- Adhere to an IRB approved protocol
- Conduct informed consent process of research subjects and teach less experienced staff how to properly perform this important task.
- Support the safety of research subjects, report adverse events
- Coordinate protocol related research procedures, study visits, and follow-up and anticipate and mitigate potential non-compliance
- Oversee and complete screening, recruiting and enrollment of research subjects while keep study priority top of mind.
- Facilitate pre--study, site qualification, study initiation, monitoring visits, and study close out activities Collect, process and ship laboratory specimens
- Follow ethical and professional codes of conduct and escalates noncompliance as needed
- Manage communication with Stakeholders: CRAs, Project Managers, Patient Services, Account Managers, Health Care practices
- Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified
- Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines, and documents data according to ALCOA.
- Foster an inclusive workplace where diversity and individual differences are valued and leveraged to achieve Elligo’s mission.
KNOWLEDGE SKILLS AND ABILITIES REQUIRED
- Bachelor's Degree, preferably in the life sciences or healthcare field preferred
- CCRC certification is a plus
- Some leadership experience preferred
- Demonstrated ability to coordinate complex protocols with overlapping timelines
- Strong organization/prioritization skills for the management of multiple concurrent projects
- Previous nursing experience in a clinical setting is a plus
- Minimum 4 years of experience in coordinating clinical trials or equivalent
- Prior GCP training and ability to explain the importance of GCP guidelines
- Previous experience with training and mentoring other clinical research professionals on the management of regulatory documents throughout the trial lifecycle
- Able to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements, and role of the IRB
- Strong attention to detail
- Demonstrated ability in positive relationship building, with strong verbal and written skills required
- Follows ethical and professional codes of conduct
- Takes action to minimize participant risk
- Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified
- Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures(SOPs), GCP guidelines, and documents data according to ALCOA.
- Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.
- Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems.
WORKING CONDITIONS
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.
All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilitiesRequirementsBachelor's Degree, preferably in the life sciences or healthcare field preferredCCRC certification is a plus Some leadership experience preferredDemonstrated ability to coordinate complex protocols with overlapping timelinesStrong organization/prioritization skills for the management of multiple concurrent projectsPrevious nursing experience in a clinical setting is a plusMinimum 4 years of experience in coordinating clinical trials or equivalentPrior GCP training and ability to explain the importance of GCP guidelinesPrevious experience with training and mentoring other clinical research professionals on the management of regulatory documents throughout the trial lifecycle Able to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements, and role of the IRBStrong attention to detailDemonstrated ability in positive relationship building, with strong verbal and written skills requiredFollows ethical and professional codes of conductTakes action to minimize participant riskAdhere to the study plan by ensuring that all approvals are in place, vendors are qualified Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures(SOPs), GCP guidelines, and documents data according to ALCOA. Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems.
