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.
Quality Assurance Manager
Summary: Responsible for day to day Quality Assurance efforts of Corporate and Study Level CRO activity. Assisting in the development, implementation of CRO Quality Management Systems (QMS) to maintain company and industry best practices with a focus on clinical quality assurance, Good Clinical Practices (GCP) and overall compliance and to ensure each study conducted at PRC is of the highest Quality standards, deliverable compliance and accuracy.
- Provide input on company procedures and policies, ensure and maintain industry compliance with applicable regulations, GXP, ICH and other regulatory and compliance requirements.
- Work closely with the Clinical Operations leaders to ensure the proper implementation and maintenance of QMS throughout conduct of all clinical studies and associated systems, including Trial Master File (TMF) organization and management.
- Review and/or contribute to development applicable SOPs and quality assurance guidance document and processes.
- Identify gaps in SOPs and ensure robust procedures are maintained.
- Manage and ensure training requirements and records for CRO staff and study teams as appropriate.
- Manage the SOP revision and distribution process according to established timelines, guidelines and procedures, including document control standards and electronic filing.
- Develop and maintain company audit plans and schedules (with appropriate input from Clinical Operations leaders).
- Responsible for client audits, vendor selection audits and regulatory inspections.
- Manage company CAPA program by overseeing issue identification, processing, documentation, resolution, and closure.
- Utilize approved QMS systems to identify and address non-compliance trends.
- Library management of paper and electronic documentation, controlled forms.
- Integrate and streamline clinical study partnered services into QMS planning and implementation.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Fluent in English (both written and verbal).
- Excellent computer skills (Microsoft Word, Excel, Outlook, etc.).
- Thorough knowledge of drug development, the project management process, FDA regulations, and ICH/GCP guidelines.
- Strong understanding of Quality Assurance practices, systems, and software, Veeva platform helpful
- Knowledge of global regulatory agencies and respective laws and guidelines.
- Proven track record of establishing and management Quality Management Systems.
- Excellent communication skills.
- Ability to utilize resources efficiently.
- Ability to lead by example, inspire teamwork, and motivate staff.
- Ability to work with CRO clients in a professional manner.
- Ability to prioritize multiple daily tasks to meet timelines.
- Ability to complete tasks accurately.
- Strong communication, interpersonal and motivational skills.
- Responsibly handle sensitive and confidential material.
- Review and process complex or diverse information and prioritize multiple tasks.
- Highly detail-oriented.
- The above qualifications may be gained through completion of a bachelor’s degree (preferably in health science) with a Masters or other advanced degree preferred.
- Applicant must also have a minimum of five years of experience in the clinical pharmaceutical industry, including demonstrated competency in Quality Management Systems (QMS), QA compliance, Quality Assurance, and Quality Control.
- Must be available for domestic/international travel including overnight stays.
Physical Demands / Work Environment:
- Working conditions typical of an office environment.
- Able to type, data entry, edit, proof read, review and comment.
- Able to interact with customers via telephone.
- Stand, walk, sit.
- Use hands, reach with hands and arms; lift or move 25 pounds.
- Speak, hear, close vision.
Clinical Research Associate – Regional Site Monitor – West Coast
A Clinical Research Associate/Site Monitor ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with Sponsors as well as clinical research investigators. This role may be the primary point of contact with the investigative site and manage all aspects of the clinical study at the site including: review of regulatory documents, Source Data Verification, site training and all other site management activities. They must prepare site visit reports and must work independently and communicate regularly with their study team manager/manager.
May be responsible for multiple projects and must work both independently and in a team environment. Perform all monitoring activities of clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols, including co-monitoring activities and quality assurance reviews.
Specific Roles and Responsibilities:
- Ensures safety and protection of study subjects according to the monitoring plan, company SOPs, ICH Guidelines, and regulations
- Performs all monitoring visits and prepares visit reports
- Performs source data verification (SDV) and query initiation, resolution and closure
- Maintains Investigator Site File (ISF) and reconciles with TMF
- Primary point of contact for all study related communications with site
- Manages the overall activities of site personnel and ensure they adhere to the study protocol including timelines
- Ensures quality of data submitted from study sites and follows up for timely submission of data
- Ensures follow through on all AEs/SAEs reporting
- Coordinates/conducts site training of protocol and operational requirements at the study start, and as needed for site personnel replacement, re-training for non-compliance, etc.
- Assists in identification of enrollment issues and participates in site specific resolution of such findings
- Identifies and escalates site issues appropriately and per the Escalation Plan defined in the Monitoring Plan
- Assists in coordinating the clinical site audit activities including pre-inspection training
- May assist in preparation of study specific templates per protocol
- Assists in reconciling differences between PRC and site developed versions of informed consents
- May serve on task forces for definition of new or revised process development, problem solving, training, etc.
- Participates in training and mentoring new or joining staff up to CRA II level as appropriate
- Participates in team meetings, teleconferences and other clinical activities as assigned
- Adapts to changing regulatory environments
- Builds positive relationships with clinical site staff and in-house project team staff
- Consistently meets project timelines while maintaining high-quality results
- Identifies issues/concerns and implements solutions and communicates issues with team management in a timely manner
- Highly detail oriented
- Excellent verbal and written communication skills
- Energetic, positive, flexible, team-oriented
- Great planning and organizational skills with effective time management
- Skilled in conflict resolution
- Confidentially handle sensitive material
- Review and process complex information and prioritize multiple tasks
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!