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Clinical Protocol Coordinator

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Bethesda, Maryland
Start date
Nov 30, 2021

View more

Discipline
Clinical, Clinical Project Management, Clinical Research
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
BioCapital

We are currently searching for a Clinical Protocol Coordinator to support activities related to clinical studies. This opportunity is part-time, and it is on site in Bethesda, MD.

 

Duties & Responsibilities
  • Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals
  • Assist researchers prepare, review, and submit clinical data to monitoring agencies
  • Assist IRB administrator collect, review, and maintain all IRB records
  • Assist staff on onsite and offsite patient scheduling issues and processes, form preparation, etc.
  • Assist staff on protocol coordination, including matching and locating control subjects, completing registration phone calls, reviewing study questionnaires, and resolving queries with patients
  • Assist researchers coordinate recruitment, scheduling, travel, and admission of research study participants with clinical staff
  • Assist researchers screen study participants and document results of screenings
  • Liaison between study participants, participants relatives and staff members and communicate participants questions, complaints, problems, and concerns to appropriate staff members
  • Develop internal research proposals, abstract submissions, poster presentations and manuscript drafts
  • Develop protocol documentation including schemas, patient calendars and teaching aids
  • Develop clinical research informed consent and other ethics and regulatory related documentation
  • 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
  • Write and edit study protocols, and amendments, reviews, reports, and other necessary forms
  • Coordinate with IRB administrator to collect, review and maintain all IRB records
  • Prepare submission documentation for regulatory bodies in support of clinical trials
  • Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids
  • Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation
  • Assist researchers develop standard operating procedures SOPs for the clinical study
  • Assist researchers prepare study reports and status updates, including amendments, audits, and other administrative documentation
  • Assist researchers collect, organize, and maintain all study documentation to include investigator qualifications, trial logs, and safety reports
  • Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports, and correspondence
  • Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms
  • Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports
  • Develop new and review completed protocol documentation including schemas, patient calendars and teaching aids
  • Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation
  • Develop new and review completed standard operating procedures SOPs for the clinical study
  • Prepare new and review completed study reports and status updates, including amendments, audits, and other administrative documentation
  • Coordinate with IRB administrator to collect, review and maintain all IRB records
  • Communicate with IRB and NIH Clinical Center for protocol approval
  • 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
  • Review completed protocol documentation including schemas, patient calendars and teaching aids and recommend changes
  • Maintain all study documentation to include investigator qualifications, trial logs, and safety reports and review for accuracy and completeness
  • Review study protocols, and amendments, reviews, reports, and other necessary forms for accuracy and completeness
  • Coordinate with IRB administrator to collect, review and maintain all IRB records
  • Communicate with IRB and NIH Clinical Center for protocol approval
  • 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
  • Maintain a master subject list for the protocols; update patients enrollment status; assign study ID numbers; obtain patient demographic information, etc.
  • 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,
  • Maintain documentation of clinical research training of staff
  • Manage, track, and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure

# SOAR

 

#LI-SK1

 

Requirements Skills
  • Strong communication skills, both oral and written
  • Clinical Trial Management System (CTMS)
  •  
Qualifications
  • Master’s degree in Health and Medical Administrative Services
  • 1-2 Years’ Experience with clinical trials, data management, database operations and management

 

 

Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

 

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) were acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at 

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.

 

 

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