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28 days old

Clinical Protocol Coordinator

Kelly Services
Baltimore, MD 21217
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a **Clinical Protocol Coordinator with the National Institutes of Health in Baltimore, Maryland.**


This is a long-term contract position which offers:

- Competitive salary with comprehensive benefit package

- Opportunity to work at NIH, the world's foremost medical research center

- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com


**OBJECTIVE:**

Provide support services to satisfy the overall operational objectives of the National Institute on Aging. The primary objective is to provide services and deliverables through performance of support services.


**TASKS:**



+ Schedule monthly NIA Clinical Investigators and Scientific Review Committee meetings.

+ Serve a central point of contact for NIA clinical research protocol activity.

+ Organize/coordinate quality assurance activities with pertinent regulatory bodies such as audits by FDA, NIH, pharmaceuticals and others.

+ Facilitate communication with IRB and NIH Clinical Center for protocol approval.

+ Interact with NIA Principal Investigators and IRB staff to coordinate amendments, annual reviews, triennial reviews, terminations, adverse events and other IRB interactions.

+ Coordinate activities regarding Investigational New Drug (IND) submissions and annual renewals.

+ Coordinate protocol-specific documentation, such as schemas, patient calendar, teaching aids, if applicable, and other activities through Study Manager TM software to provide protocol schedules at the start of a new study.

+ Coordinate/schedule protocol initiation meeting with appropriate staff.

+ Facilitate protocol updates, amendments and other documents as needed to obtain IRB approval.

+ Maintain documentation of clinical research training (by OHRP, the Clinical Center and others) of clinical researchers as required by the IRB, NIH and others.

+ Coordinate education and guidance regarding research activities, procedures and standards for new staff members as needed and as directed by the NIA Project Officer.

+ Develop and maintain knowledge of and performance of job functions in compliance with all applicable rules, regulations, policies and statutes.

+ Assists researchers collect, distribute and file regulatory documents.

+ Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.

+ Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others. Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.

+ Assist researchers prepare submissions to regulatory bodies in support of clinical trials.

+ Develops and maintains trial related documents and operational procedures.

+ Collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.

+ Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.

+ Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports.

+ Collects and distributes regulatory documents.

+ Coordinate with IRB administrator to collect, review and maintain all IRB records.

+ Review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.

+ Prepare and submit documentation for regulatory bodies in support of clinical trials.

+ Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.

+ Reviews and recommends changes to clinical trial documents.

+ Review completed protocol documentation including schemas, patient calendars and teaching aids and recommend changes.

+ Review completed clinical research informed consent and other ethics and regulatory related documentation and recommend changes.

+ Review completed standard operating procedures (SOPs) for the clinical study and recommend changes.

+ Review completed study reports and status updates, including amendments, audits and other administrative documentation and recommend changes.

+ Review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports and recommend changes.

+ Reviews and maintains trial related documents and operational procedures.

+ Maintain all study documentation to include investigator qualifications, trial logs, and safety reports and review for accuracy and completeness.

+ Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments,

+ Develops training plans and trains staff on the proper techniques for protocol submission.

+ Coordinate education and guidance regarding research activities, procedures and standards for new staff members. Maintain documentation of clinical research training of staff.

+ Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.


**REQUIREMENTS.** The contractor must have:


Certifications & Licenses

- Bachelors degree in a related discipline, Master's preferred - at least 5

years of related work experience

Field of Study

- Biology - Health and Medical Administrative Services -

General Medical and Health Services

Software

- MS Office Suite - iRIS

Skills

- Strong communications skills, both oral and written. - Liaising

with regulatory authorities - Coordinating project meetings


Work Location: Baltimore, MD 21225


When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position.


Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you arent contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.


As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats next.


It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Government Solutions?**


Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the worlds most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Categories

Posted: 2022-08-31 Expires: 2022-10-01

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Clinical Protocol Coordinator

Kelly Services
Baltimore, MD 21217

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