Clinical Research Coordinator II

Overview Kelly Science and Clinical FSP is currently seeking a Contract Clinical Research Coordinator II in New Bedford, Massachusetts. This role is full-time within the Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. The role offers full benefit options and eligibility for Medical, Dental, Vision, 401K and other benefits. Paid time off (including holiday, vacation, and sick/personal time) may also be available. Responsibilities Coordinate efforts with study team members to achieve protocol objectives and corporate goals. Develop strong working relationships and maintain effective communication with study team members, the clinic, and sponsors for clinic-related activities. Manage multiple concurrent trials. Mentor and train study team members; complete all protocol-related training. Schedule patients/research participants and collect patient/research participant history. Collect, maintain, and review 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 supplies, imaging, laboratory handling manuals). Adhere to an IRB-approved protocol and conduct the informed consent process of research subjects. Support the safety of research subjects and report adverse events. Coordinate protocol-related procedures, study visits, and follow-up; anticipate and mitigate potential non-compliance. Assist with screening, recruiting, and enrollment of research subjects. Facilitate pre-study activities, site qualification, study initiation, monitoring visits, and study close-out. 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). Ensure study plan approvals are in place and vendors are qualified; comply with clinic and sponsor policies, SOPs, GCP guidelines, and ALCOA data documentation. Demonstrate proficiency with MS Office and clinical trial master filing systems; travel to Clinic activities, investigator meetings, or vendor visits/audits as required. Demonstrate strong organization and prioritization skills for managing multiple concurrent projects. Qualifications/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 is a plus. CCRC certification is a plus. Demonstrated ability to build positive working relationships with strong verbal and written communication skills. Knowledge of clinical trial terminology and practices; ability to coordinate complex protocols with overlapping timelines. Prior GCP training and ability to explain the importance of GCP guidelines. Management of regulatory documents throughout the trial lifecycle; ability to train others on key protocol elements and study task execution. Able to clearly explain and enforce participant safety requirements, including ICF elements and the role of the IRB. Strong attention to detail and interpersonal skills; follow ethical and professional codes of conduct. Take action to minimize participant risk; adhere to the study plan and ensure vendors are qualified. Comply with clinic and sponsor policies, SOPs, and guidelines (GCP) and document data according to ALCOA. Proficiency with word processing, spreadsheets, databases, presentation software (MS Office) and with clinical trial master filing systems. Ability to travel for clinic activities and attend investigator meetings or vendor visits/audits as required. Working Conditions The statements describe the general nature and level of work performed by individuals assigned to this position and are not intended to be an exhaustive list of responsibilities, duties, and skills required. More in-depth information can be found in SOPs, working guidelines, and policies. #J-18808-Ljbffr