Clinical Protocol Coordinator

Location
Bethesda, Maryland
Posted
Jan 15, 2022
Ref
2022-11399
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

The purpose of this position is to support activities related to clinical studies.

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

#LI-SK1

 

#LI-JR1

Requirements Skills
  • Write and coordinate submission of protocols to the Institutional Review Board (IRB).
  • Work with staff on all facets of clinical studies including subject enrollment, investigation consent, subject longitudinal monitoring, study data collection and data entry.
  • Plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
  • Plan, implement and maintain data collection and analysis systems in support of research protocol; coordinate the collection and analysis of research data.
  • Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
  • Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol; perform aspects of research protocol, in accordance with specified program objectives.
  • Organize and facilitate meetings, conferences and other events associated with research activities; perform and/or coordinate outreach activities, as appropriate to research objectives.
  • Document all correspondence and communication pertinent to research.
  • Interact with and maintain communication with Principal Investigator, other site personnel and research participants.
  • Complete required and applicable research training needed to complete research.
  • Create and adhere to a data quality and quality assurance plan.
  • Maintain and update fi les of all applicable regulatory documentation for IRB (including protocols, approvals, amendments, modifi cations, etc.) and any communications with the sponsor or any other Federal or regulatory offi ce (including prior approvals, change in scope, etc.).
  • Maintain current knowledge of the IRB process including document preparation and interfacing with IRB personnel.
  • Promote safety and confi dentiality of research participants at all times.
  • Adhere to Occupational Safety and health Administration (OSHA), Good ClinicalPractices (GCP), Good Laboratory Practices (GLP) and infection-control- procedures (bio-specimen collection and shipment).
  • Strong communication skills, both oral and written

 

Qualifications
  • Masters Degree
  • Minimum1-2 years experience

 

 

 

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) was 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 RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

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.