Job Description

Description Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH, GCP, protocol, and company guidelines, regulations, and policies. ICH: International Conference on Harmonization GCP: Good Clinical Practices MUST HAVE: 1+ yr industry experience at a CRC, EKG, patient visits, SIV (no phlebotomy). Essential Responsibilities and Duties: - Coordinates all aspects of patient involvement from study initiation until study completion. - Study start-up activities: Assists in the creation of thorough and accurate source documents. - Study start-up activities: Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members. - Study start-up activities: Participates in IMs (Inclusion Management) and SIVs (Site Initiation Visits); communicating with sponsors and representatives. - Study start-up activities: Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.). - Screening and enrolling activities: Assists in reviewing all participant history from Pre-Enrollment and Enrollment departments confirming information with potential participant and study physician. - Screening and enrolling activities: Educates potential participants and caregivers on protocol specific details and expectations. - Screening and enrolling activities: Works with the physician to address all questions and concerns related to the trial and informed consent process. - Screening and enrolling activities: Maintains thorough knowledge of study specific inclusion/exclusion criteria. - Coordinates scheduled visits, adhering to protocol visit windows and timelines. - Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). - Collaborates with the research pharmacist to perform drug accountability and compliance at each visit and educating subject on proper dosing regimen. - Accurate and timely completion of source documents recording subject's participation in study. - Communicates closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines. - Assists investigators in collection of information from study subjects regarding AEs (Adverse Events), concomitant medications and other changes throughout participation. - Timely reporting of study status, study related issues, and study events (SAEs (serious adverse events), protocol deviations, etc) to appropriate management, internal departments and other outside agencies (Sponsors, CRO's (contract research organization), etc.) - Responsible for subject scheduling and follows subjects through study completion and creates follow-up care plan with physician, study subject and primary care provider. - Prepares and facilitates all study monitoring visits and follows up promptly with monitor follow-up letters. - Prompt and professional communication with sponsors, representatives and other study related parties. - Maintains professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff members. - Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Skills clinical research Top Skills Details clinical research Additional Skills & Qualifications - Education or Experience Requirement... - Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. - Strong leadership and mentorship skills. - Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. - Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. - Works independently as well as functioning as part of a team. - Proficient in the use of technology required for the completion of study visits and study conduct. - High level of ability to complete paperwork with precision, accuracy, and attention to detail; meet timelines; and prioritization. - Experience with medical equipment and instruments to administer study subject care. - Knowledge of medical terminology. - Must be able to effectively communicate verbally and in writing. Experience Level Entry Level Pay and Benefits The pay range for this position is $58240.00 - $87360.00/yr. Benefits package available.Client observes 7 holidays annually including: New Years Day, Memorial Day, Independence Day, Labor Day, Thanksgiving, the day after Thanksgiving, & Christmas. Workplace Type This is a fully onsite position in Toms River,NJ. Application Deadline This position is anticipated to close on Nov 3, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.

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