Clinical Research Coordinator II (New Bedford)

Kelly Science and Clinical FSP is currently seeking a Contract Clinical Research Coordinator II in New Bedford, Massachusetts. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.DescriptionJOB SUMMARY(To perform this job satisfactorily, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.)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, including:ESSENTIAL DUTIESDevelop 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 trialsAssist with mentoring and training study team membersComplete all protocol-related trainingPerform patient/research participant schedulingCollect patient/research participant historyCollects and maintains source documentationPerforms data entry and query resolutionCollect 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 protocolConduct the informed consent process of research subjects.Support the safety of research subjects, report adverse eventsCoordinate protocol-related research procedures, study visits, and follow-up and anticipate and mitigate potential non-complianceAssist with the screening, recruiting, and enrollment of research subjects.Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activitiesCollect, process, and ship laboratory specimensFollow ethical and professional codes of conduct and escalate noncompliance as neededCommunicate with Stakeholders: CRAs, Project Managers, Patient Services, Account Managers, healthcare practicesAdhere to the study plan by ensuring that all approvals are in place, vendors are qualifiedComply with Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines, and documents data according to ALCOA.Comply with Clinic, and Sponsor policies, standard operating procedures (SOPs), and guidelines.WORKING CONDITIONSThe 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.RequirementsKNOWLEDGE SKILLS AND ABILITIES REQUIREDMinimum 3 years of experience coordinating clinical trials, including the activities listed aboveBS/BA in Life Science or related discipline or equivalent work experiencePrevious nursing experience in a clinical setting a plusCCRC certification a plusDemonstrated ability in positive relationship building, with strong verbal and written skills required.Knowledge of clinical trial terminology and practices requiredDemonstrated ability to coordinate complex protocols with overlapping timelinesPrior GCP training and ability to explain importance of GCP guidelinesManagement of regulatory documents throughout trial lifecycleAbility to train others on key protocol elements and study task executionAble to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements and role of the IRBStrong interpersonal skills with attention to detail a mustFollow ethical and professional codes of conductTake action to minimize participant riskAdhere to the study plan by ensuring that all approvals are in place, vendors are qualifiedComply with Clinic, and Sponsor policies, standard operating procedures(SOPs), GCP guidelines and documents data according to ALCOADemonstrated 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