Contract & Permanent CRAs (NJ)-several positions for 6 months to 1 year assignments

NOTE: Based out of HQ

Monitor and manage all clinical trials Phase 1-3 according to current regulations, GCP and SOP requirements. Key responsibilities are to identify and propose potential trial investigators, negotiate site trial agreements including budgets and contracts, assure timely availability of all trial materials and documentation at trial site, obtain and maintain trial master file documents, participate and train at investigators meetings as appropriate, perform source document verification procedures according to SOPs and trial specific requirements, ensure CRFs are provided to centers and are complete, legible and accurately reflect the source data, ensure appropriate reporting of adverse events by investigators according to GCP and SOPs, ensure investigator and other site personnel compliance with the protocol and trial procedures, train on-site team of the investigator and other site personnel in proper conduct of clinical trials, perform qualification, initiation, monitoring and close up tasks as required by GCP, SOPs and study protocol, review CRFs and request corrections of entries as required, monitor SAE reporting and request primary and follow up information according to SOP, review protocol violations with the investigator and take corrective actions to prevent continued non-compliance, provide timely monitoring reports in accordance with SOPs, input into CRF design, prepare and review amendments and ensure appropriate approvals from sites, verify shipment of study supplies and assist with additional tasks as required.

BS or BSN with minimum of 5 years of experience or MS with 3 years. Must possess a thorough understanding of GCP, the clinical trial processes and internal SOPs. Must be able to work in a team environment. Must be fluent in spoken and written English. Should have excellent organizational skills with the ability to prioritize multiple projects and tasks. May lead and direct the work of others. Computer literacy, familiarity with MS Office and MS project preferred

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Associate Director, Clinical Affairs (CA)

Responsible for strategic operational management of portfolio of clinical programs in Medical Affairs. Effectively leads a team of Clinical Affairs Managers to meet project goals and attain deliverables in all phases of clinical programs. Facilitates cross-functional partnerships internally and externally to Medical Affairs. Manages alignment between the Unit and the Product Development Project Team Structure in the areas of budget, resources and timelines. Ensures excellent management of the Clinical Affairs, and Clinical Research Professional job family within Unit and across Medical Affairs. Effectively partners and provides resources to ensure the successful implementation of Medical Affairs Strategic Initiatives.

BS/RN/MS degree in biological science, health science or equivalent; MBA or other advanced degree desirable. Minimum 10 years experience in clinical research. Minimum 5 years experience staff management, including leading other managers. Robust experience in planning, resourcing and managing multiple, complex, multifaceted clinical programs, phase I-IV

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Clinical Contracts Manager (NJ)
This key individual will work to obtain/negotiate cost-effective contracts for external clinical research and laboratory services, manages the vendor selection process, act as team leader in evaluating and selecting providers for outsourced services, initial develop, negotiate various clinical agreements, change orders, and amendments for outsourced services. Additionally, will monitor selected CROs to monitor for quality and interact with QA, company sites, and the CRO to evaluate and improve quality. This person will also be responsible and accountable for the successful implementation of individual high value outsourcing business improvement projects within his/her assigned area of development. This person will lead the project from concept to launch, facilitate the team process, collaborate with cross-divisional project teams and execute the project plan, act as liasion between the project office, business sponsor(s), and the organization, and monitor the progress of the project. We require at least 3 years of experience in the pharmaceutical industry with emphasis in negotiating contracts. This person will have an understanding of the clinical research process and demonstrate the ability to interface with clinical researchers and CROs. BA degree in Science or Business, MBA or a law degree.

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Senior CRA (CA, IL, MA, NY, NJ, CT)
Our client is seeking several Senior CRAs to become part of a premier organization. Actual position offered commensurate with experience and skills.

The primary focus of the Sr. CRA is on the implementation of a clinical study, specifically study monitoring and site management responsibilities. The CTM is the primary contact between the study site staff and company; responsibilities include collection and maintenance of regulatory documentation, protocol compliance, discrepancy management, accurate and complete data collection (including case report forms and biological samples), and adverse event reporting. The CTM candidate must have knowledge of FDA regulations and their practical implementation; as well as the ability to work with inter/intradepartmental staff.

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Clinical Operations Managers (CA)
In conjunction with other departmental groups, set strategic vision and plan for clinical trials, projects. Direct the successful execution of development and commercial programs; Manage and facilitate cross-functional teams; Responsible for setting study/project objectives; Designs, implements and manages logistical operations via a cross-functional study/project team. Responsible for creating and tracking study/project timelines, deliverables and budgets: Facilitates protocol, case report form, adverse event form development; Oversees data collection, dissemination and safety reporting. People management: Responsible for effective management of typically 3-5 people. Requirements: Minimum of 5 years industry experience in drug development and/or commercialization.

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Medical Director, Clinical Research (MA)
We are currently searching for a Pulmonologist that will be will be responsible for providing strategic and clinical input into specific development programs, related to company products. Working with Clinical Operations, will design and prepare clinical trials protocols, data analysis and review plans for assigned development programs. Review and interpret clinical trial data, determining clinical significance of results and amending clinical development plan as appropriate. Review and analyze program specific safety data, including clinical trial adverse events, objective findings and on-going review of serious adverse events. Working closely with Clinical Safety group, insure on-going risk assessment of assigned development programs. Assist in the update of the Investigator's Brochure and Annual reports. Work closely with contracted medical monitor and investigative sites when necessary. Requirements: MD required, preferably with an immunology/pulmonology background. Educational or industry experience in the respiratory therapeutic area also desirable. The candidate should have experience of 1-3 years within the pharmaceutical industry. Would consider a physician candidate with strong academic and scientific experience and drug development experience as a clinical investigator.

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CRA I (MA)
Under general supervision, the Clinical Research Associate I performs clinical monitoring activities to assure site compliance with study protocols and GCP. Responsibilities include but are not limited to performing monitoring visits, maintaining contact with study sites, report preparation and communications documentation.

Required qualifications: Associate's degree or equivalent combination of education and experience in a medical or scientific discipline; significant technical, medical or industry experience in a clinical research setting; strong understanding of Medical Terminology, Physiology, and Pathophysiology; basic understanding of Good Clinical Practices; strong organizational skills; the ability to multi-task; the ability to manage multiple study sites and multiple studies; strong written and verbal communication and diplomacy skills; professional demeanor and appearance; ability to travel 50-70%.

Preferred qualifications: BS in scientific discipline; 2 years experience in a CRO.

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Lead CRA (MA)
This is a lead position. The Clinical Research Associate II manages the implementation of study protocols at research sites. Responsibilities include but are not limited to: serving as lead CRA for clinical studies; performing monitoring visits including site qualification, initiation, monitoring and closeout visits; developing monitoring plan; maintaining contact with study sites, report preparation and communications documentation; conducting training; preparing for and participating in Sponsor and FDA audits; managing clinical assistants and associates. Required qualifications: AA degree or equivalent combination of education and experience in a medical or scientific discipline; minimum 1 year monitoring experience; significant technical, medical or industry experience in a clinical research setting; strong understanding of Medical Terminology, Physiology, and Pathophysiology; working knowledge of Good Clinical Practices; strong organizational skills; the ability to multi-task and work effectively in a fast-paced environment; strong written and verbal communication and diplomacy skills; professional demeanor and appearance; ability to travel 30%.

Preferred qualifications: BS in scientific discipline; 2+ years experience in a CRO.

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CRA (NY)
Tracking of Clinical trial supplies; assists with recruitment of potential investigators, organization of meetings and other tasks as instructed by the Senior CRA/Clinical Project Manager; assist with activities related to pre-site, initiation, interim, and close-out visits. Prepare accurate and timely trip reports, recommending corrective action where appropriate; Coordinate investigational drug shipments and product disposition at sites; Establish, update, track and maintain study specific trial management tools/systems; Maintain regular contact with sites; Maintain written correspondence with sites; In-house review of CRFs and query resolution; Full understanding of the SAE reporting process; Participate in the design of Case Report Forms (CRFs) for research data collection of patient safety and efficacy parameters as required by study protocol, federal regulations, and GCPs; Participate in the review of study specific monitoring guidelines, source document templates, statistical analysis plans, and reports; Assist in the development and implementation of company SOPs relating to clinical research; Act independently as liaison between Senior CRA/Clinical Project Manager and investigational clinical sites; Communicate progress of study and relevant information to Senior CRA/Clinical Project Manager and other team members; Assist Senior CRA/Clinical Project Manager and other project staff in distribution and tracking of site budgets, contracts, and regulatory documents; May assist with training and development of new employees, e.g. co-monitoring. Travel approximately 40-50%, depending on needs of study protocol (project driven). QUALIFICATIONS: Requires a BS/BA;Minimum of 2 years experience in clinical research or clinical trial monitoring.

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