About the position
This individual will play a key role in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, the ability to prioritize, a “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills. The CRC II will have overall responsibilities for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals.
Responsibilities
- 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.
- Complete all protocol-related training.
- Perform patient/research participant scheduling.
- Collect patient/research participant history.
- Collect and maintain source documentation.
- Perform data entry and query resolution.
- Collect and review 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 the informed consent process of research subjects.
- 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.
- Assist with the screening, recruiting, and enrollment of research subjects.
- 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 escalate noncompliance as needed.
- Communicate with Stakeholders: CRAs, Project Managers, Patient Services, Account Managers, healthcare 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.
Requirements
- Minimum 3 years of experience coordinating clinical trials, including the activities listed above.
- BS/BA in Life Science or related discipline or equivalent work experience.
- Previous nursing experience in a clinical setting a plus.
- CCRC certification a plus.
- Demonstrated ability in positive relationship building, with strong verbal and written skills required.
- Knowledge of clinical trial terminology and practices required.
- Demonstrated ability to coordinate complex protocols with overlapping timelines.
- Prior GCP training and ability to explain importance of GCP guidelines.
- Management of regulatory documents throughout trial lifecycle.
- Ability to train others on key protocol elements and study task execution.
- Able to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements and role of the IRB.
- Strong interpersonal skills with attention to detail a must.
- Follow ethical and professional codes of conduct.
- Take 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.
- 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.
- Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.
- Strong organization/prioritization skills for the management of multiple concurrent projects.
