Are you ready to join a high touch team? Our mission is to exceed the level of service offered by large CROs.
PRC Clinical is the CRO of choice for many pharmaceutical, biotech and regenerative medicine developers worldwide, offering a next-level clinical trial management experience. We have significant CRO experience in a wide range of therapeutic areas: Regenerative Medicine, CNS, Neurology, ALS, Parkinson’s, Pain, GI, Device, Anti-infective, Cardiovascular, Pulmonary, Oncology, Endocrine, and Stem cells.
Our strategy isn’t just to grow – but also to retain exceptional talent. We’re building our infrastructure around people in a positive working environment and understand that opportunities for advancement lead to greater satisfaction at work and at home. With competitive compensation packages and benefits, rewards for your team contributions and achievements will be recognized and acknowledged by incentive bonuses, leadership positions, and promotions within the company. We offer flexibility of work hours and many other attractive options.
Clinical Operations Director
The Clinical Operations Director leads all aspects of Clinical Operations ranging from working closely with CRO Senior Management to providing strategic and tactical guidance and support for clinical staff, ensuring GCP compliance and a high degree of quality deliverables to CRO management and sponsor clients.
This is a full-time in-house position with minimal supervision and may require occasional travel.
- Member of senior management team engaged in developing key company strategies to meet company goals and objectives, serving as executive oversight and project director roles.
- Work with management, study staff, partners and sponsors to provide strategy and planning for successful implementation and conduct of all aspects of phase I -IV clinical research studies.
- Maintain collaborative relationships with sponsors, key opinion leaders, investigators, and other key individuals as necessary to ensure appropriate study progress and overall business and clinical objectives.
- Participate and support Business Development in the sales process of securing new clinical studies by contributing to proposals, providing resource strategies, planning and bid defense presentations.
- Responsible to senior management for the clinical operations department including staff resource allocations, timelines, and accountability for budgets and financial projections by project and sponsor.
- Oversee all clinical staff including study managers, service partners for DM, biostatistics, pharmacovigilance and laboratories.
- Ensure GCP and Quality Assurance compliance processes are embedded and adhered to in each project deliverable, including company, department and team trainings as appropriate (including but not limited to SOP requirements and ICH guidelines).
- Lead the efforts to develop and refine processes to govern all Clinical Operations and CRO activities within the Clinical Operations including evaluating partner services, operational systems and related SOPs, such as study planning, feasibility of sites and Investigators, and the conduct of clinical trials.
- Work with Quality Assurance Manager to optimize and implement SOPs, processes, communication, and infrastructure.
Operations Department to support CRO goals
- Manage and represent clinical operations plans and status to management, subordinate staff, partners and sponsors.
- Ongoing calibration and optimization of study activities including timeline, enrollment goals and budget fitness.
- Enhance study teams by education and knowledge, leveraging experience to execute functional roles of clinical study.
- Identify, implement and maintain cutting-edge technologies and tools to maximize CRO and study processes.
- Develop and present management and sponsor client analytics and metrics reports to convey department and study status reporting.
- Other duties in support of CRO as assigned.
- CRO management experience required.
- Advance knowledge of drug development process.
- Proficient in MS Office environment; easily adapt to computer programs and platforms.
- Ability to work under pressure in fast-paced environment.
- Demonstrated leaderships, motivation and communication skills.
- Deep understanding of GCP/ICH, US FDA/Regulatory submission processes.
- Experience in the execution of complex trials and indications: stem cell, gene therapy, tissue, rare, orphan trials, regenerative medicine, neurology, ophthalmology, oncology preferred.
- Advanced Degree, BA or BS in a related field required. Graduate degree in health-related field highly preferred.
- 10+ years of pharmaceutical, biotech Industry sponsored trial related experience.
- Certificates in Project Management, Gantt Development, Clinical Quality helpful.
- Excellent verbal communication skills and mastery of written English language.
- Willingness to travel as needed.
- Advanced-level skills in MS Office programs: formulas, formatting, creating, developing, editing, documents, spreadsheets and presentations.
Clinical Trial Manager
This is a fulltime in-house position located in San Bruno, CA. This role will be responsible for overseeing and developing the clinical operations and administrative staff. This position will report to the director of clinical operations and will be responsible for the direct reports as well as have some duties involving Sponsor contact. This position may have occasional travel for training, mentoring and hands on evaluation of regional staff.
Description of job duties:
- Line management of in-house staff and regional Clinical Research Associates (CRAs)
- Team advocate to ensure appropriate responsibility and accountability of all team members
- Recruit and screen for the hiring of additional staff
- Training and development of clinical staff of protocols, medical and scientific study areas, good clinical practices and other industry standards
- Oversight and Management of CRAs to ensure Sponsor satisfaction and expectations are met
- Tracking and management of CRA resourcing/allocation of project assignment and work-load
- Manage turnover and retention of CRAs to meet PRC and sponsor objectives
- Other related duties as necessary
- Bachelor’s degree with 4-6 years pharmaceutical industry experience (site monitoring project management) including direct supervisor experience;
- Understanding of Good Clinical Practice and regulatory environmentStrong leadership, mentoring, and motivational skills;
- Effective written and verbal communication skills;
- Current business software skills
- Competitive salaries, incentive bonus and a full range of benefits including: Medical, dental, life, disability insurance coverage, 401k with generous match, PTO and bonuses based on yours and
- PRC’s performance and access to the onsite fitness center.
- 7+ years CRA experience in oncology, neurology, pulmonary, or infectious disease, working knowledge of regulatory and drug development process, data management and EDC, and exposure to the contracts/budget process.
- This position will interact with other teams and departments and act as the primary contact for vendors/CRO giving technical guidance and direction to external team members and vendors.
- The CRA will contribute to the overall study team and perform the usual functions of an in-house CRA including assist with the development of the study plan, reviewing informed consents, site-monitoring, site budget and payments; reconcile differences in site data; proactively monitor site supply requirements; recognize and propose resource needs; produce accurate and well-represented documents.
1099/W2 positions available – full time and part time work. Some travel may be required.
Clinical Project Internship
Get the experience necessary to enter the pharmaceutical and biotech clinical research industry. You will gain valuable experience from the CRO to Sponsor perspective. Some of the job duties include: making client regulatory and SOP binders, participating in meetings and teleconference, administrative support, updating spreadsheets, and communication with investigator sites as well as pharmaceutical and biotech sponsors.
Requirements: BS degree. Proficiency with MS Office. Clinical knowledge, past/current enrollment in an Clinical Trials Design education program is helpful.
Thank you for submitting your application!